Medical Policy

 

Subject: Sacroiliac Joint Fusion
Document #: SURG.00127 Publish Date:    02/28/2018
Status: Reviewed Last Review Date:    01/25/2018

Description/Scope

This document addresses proposed indications for sacroiliac joint fusion, a surgical procedure which fuses the iliac bone (pelvis) to the spine (sacrum). It is performed for a variety of orthopedic conditions including trauma (with fracture), infection, cancer, and spinal instability.

For additional information, please refer to the following related documents:

Position Statement

Medically Necessary:

Sacroiliac joint fusion procedures are considered medically necessary for any of the following indications:

  1. As an adjunct to sacrectomy or partial sacrectomy related to tumors involving the sacrum; or
  2. As an adjunct to the medical treatment of sacroiliac joint infection/sepsis; or
  3. Severe traumatic injuries associated with pelvic ring disruption (that is, fracture or dislocation); or
  4. During multisegment spinal constructs (for example, correction of deformity in scoliosis or kyphosis surgery) extending to the ilium.

Investigational and Not Medically Necessary:

  1. Sacroiliac joint fusion procedures for conditions not listed above, including but not limited to, mechanical back pain due to sacroiliac joint syndrome and sacral insufficiency fractures, are considered investigational and not medically necessary.
  2. Minimally invasive sacroiliac joint fusion and percutaneous sacroiliac joint fusion procedures are considered investigational and not medically necessary.
Rationale

Sacroiliac Joint Fusion as an Adjunct to Sacrectomy or Partial Sacrectomy Related to Tumors Involving the Sacrum

Surgical management of primary sacral tumors is challenging because of their size and location. Reconstruction is often required in individuals who require a radical resection with total sacrectomy for tumors such as chordoma, chondrosarcoma, Ewing sarcoma, and giant cell tumor of the sacrum. Sacroiliac joint fusion has been performed as an adjunct to en bloc sacrectomy or partial sacrectomy in the setting of sacral tumors. The evidence in the peer-reviewed literature to support the use of lumbar pedicle screws in combination with other surgical techniques involving the ilia in spinal pelvic reconstruction surgery (for example, Galveston rods, transiliac bar placement) consists of articles that review surgical techniques (Zhang, 2003) and small case series (Gallia, 2005; Newman, 2009; Salehi, 2002).

Sacroiliac Joint Fusion as an Adjunct to the Medical Treatment of Sacroiliac Joint Infection/Sepsis

Sacroiliac joint infection (such as, osteomyelitis, pyogenic sacroiliitis, sepsis) is an uncommon condition that generally responds to long-term antibiotics and occasionally requires drainage for abscess. Additional surgical treatment may involve debridement, decompression, and internal screw fixation when symptoms do not resolve with initial intravenous antibiotic therapy. The evidence in the peer-reviewed literature to support the use of sacroiliac joint fusion as an adjunct to the medical treatment of sacroiliac joint infection consists of single and small case series (Davidson, 2003; Giannoudis, 2007; Sar, 2003).

Sacroiliac Joint Fusion for Severe Traumatic Injuries Associated with Pelvic Ring Fracture

Pelvic ring disruption with sacral fracture is typically a result of a high-energy injury associated with vascular injuries, mechanical instability, neurological impairment and increased morbidity. Unstable pelvic ring fractures can be treated by a variety of methods including early operative stabilization with internal iliosacral screw fixation. In vertically unstable injuries, sacroiliac screws may be augmented by anterior fixation (Griffin, 2006). Low rates of infection, wound healing problems and minimal blood loss are advantages of this method.

The evidence in the peer-reviewed literature to support the use of sacroiliac joint fusion procedures for pelvic ring fracture associated with traumatic injury consists of retrospective case series that address advantages and complications of specific surgical approaches (Hsu, 2010; Peng, 2006; Rysavy, 2010; Schweitzer, 2008).

Sacroiliac Joint Fusion in Multisegment Spinal Constructs Extending to the Ilium

Spinal deformity surgery involving long fusions of the spine in adults with spinal diseases such as degenerative scoliosis and spondylolysis may result in a debilitating complication of failure of the lumbosacral (spinal-pelvic) junction resulting from nonunion, implant failure, or sacral fracture. As a result, individuals who experience continued pain, continued curve progression and deformity, and progressive sagittal imbalance, may require reoperation. The addition of spinopelvic fixation at the caudal end of long segment fusions (constructs) has improved sacral fusion rates. Iliac wing screws have been successfully used in nonambulatory individuals for the treatment of neuromuscular scoliosis, but concerns exist over use in ambulatory individuals. Sacroiliac joint fusion has been performed in the setting of long segment fusions of the spine that end at the first sacral vertebra (S1) in adults with spinal deformity and persistent sacroiliac joint-related pain. The evidence in the peer-reviewed literature consists of retrospective case series (Tumialan, 2008; n=20), the largest series involving 78 ambulatory adults with degenerative scoliosis and spondylolysis who underwent bilateral iliac wing fixation in long fusions to the pelvis (Kasten, 2010). The operative indications for posterior spinal fusion in this case series were fixed sagittal imbalance spondylolysis (n=23), idiopathic scoliosis (n=22), degenerative scoliosis (n=15), pseudarthrosis below long fusions (n=13), and traumatic kyphosis (n=5). Postoperatively, 12 of 78 individuals (15.3%) developed pseudarthrosis with broken implants; however, only 5 of 78 (6.4%) nonunions occurred at the lumbosacral junction. Six of 78 individuals (7.7%) required removal of the iliac screws for pain or painful prominence. A total of 42 individuals had one or more complications with an overall complication rate of 54%. Based on responses to a satisfaction questionnaire, 78% of individuals reported good or excellent results with the procedure. A significant improvement was achieved in correction of sagittal balance and coronal deformity. On follow-up radiographs, there were no sacral fractures, sacral screw failures, or significant sacroiliac joint degeneration. Nonunions continued to be a problem, with a rate of 15.3%, however only 6.4% of nonunions were at the lumbosacral junction. Complications specific to iliac screw placement were reported as minimal. Despite the complication rates (similar to those reported in other articles) and the known problems that exist with the complexity of long segment spinal fusions, the use of iliac wing fixation appears to improve lumbosacral fusion rates by adding structural support to S1 screws in long-segment spinal fusions.  

Sacroiliac Joint Fusion for Pelvic Girdle Pain

A European guideline by Vleeming and colleagues (2008) suggests that surgery may be indicated for severe traumatic cases of pelvic girdle pain, but only when other non-operative treatment modalities have failed. The guideline recommends a preoperative assessment and trial with an external fixator for 3 weeks to evaluate longer lasting effects of fixation.

Kibsgard and colleagues (2014) evaluated physical function and pain after open-accessed unilateral anterior sacroiliac joint fusion and fusion of the pubic symphysis in a single-subject research design study of 9 individuals with severe pelvic girdle pain. Repeated outcome measures of Oswestry Disability Index (ODI), visual analogue scale (VAS), and Short Form-36 (SF-36) were assessed preoperatively and at 3, 6, and 12 months postoperatively. A total of 8 participants were evaluable and included in the 1 year analysis of outcomes. Significant reductions were reported in ODI (54 to 37) and VAS (82 to 57) scores after 1 year (p<0.001). At baseline, 7 out of 8 participants had bilateral SI joint symptoms. At the 1-year follow-up, only 2 participants experienced pain in the fused joint; however, 6 of the 7 participants reported discomfort in the contralateral side. A total of 7 participants had pain in the pubic symphysis before surgery, and 5 participants had persistent pain in this area at the 1-year follow-up. One year after surgery, there was a 20-point improvement in physical function and bodily pain (p<0.001), a 15-point improvement in social functioning (p=0.008) and a 6-point improvement in general health (p=0.009). There were 3 major complications reported: 1 infection, 1 complex regional pain syndrome with drop-foot, and 1 participant with loss of bladder sensation; in addition, 3 participants experienced transient sensitivity loss to the lateral femoral cutaneous nerve area. All participants reported high levels of postoperative pain and required epidural treatment for 5-7 days, were hospitalized for 7-10 days, and were discharged on opioids. Limitations of this small study include the short-term measurement of outcomes and the high incidence of adverse events and complications with the procedure. Additional studies are needed of larger populations measuring long-term outcomes to evaluate the clinical efficacy and safety of sacroiliac fusion of the pelvic joints for individuals with severe pelvic girdle pain.

Sacroiliac Joint Pain and other Pain-related Sacroiliac Conditions

Research into sacroiliac joint pain has been affected by lack of standard criteria to measure its prevalence and against which various clinical examinations can be validated. Sacroiliac joint pain is typically without any consistent, demonstrable radiographic or laboratory features and most commonly exists in the setting of morphologically normal joints. Diagnostic anesthetic injections, movement tests, palpation to detect tenderness, and pain descriptions are clinical tests for evaluating individuals with complaints of sacroiliac joint pain. Study of the sacroiliac joint is further confounded by multiple structures, such as lumbar discs and posterior facet joints, that may refer pain to the area surrounding the sacroiliac joint. Sacroiliac joint fusion, whether performed as an open or minimally invasive (percutaneous) surgical procedure, with or without bone grafts and other metal implant devices, has been investigated as a treatment for individuals who are unresponsive to or cannot tolerate other therapy for chronic low back pain presumed to be primarily of sacroiliac joint origin and other pain-related sacroiliac conditions.

A small consecutive case series (Al-Khayer, 2008) and prospective cohort study (Wise and Dall, 2008) reported a reduction in postoperative low back pain and improvement in subjective measures of satisfaction after percutaneous sacroiliac joint arthrodesis utilizing screws or fusion cages filled with bone morphogenic protein for individuals with chronic or intractable sacroiliac joint pain.

Two case series were reported in 2012 on the iFuse Implant System® (SI-Bone, Inc., San Jose, CA) for minimally invasive fusion of the sacroiliac joint (Rudolf, 2012; Sachs, 2012). An orthopedic spinal surgeon in private practice (Rudolf, 2012) retrospectively analyzed his first 50 consecutive cases of individuals treated with the iFuse Implant System, a series of triangular, porous plasma spray coated titanium implants. Medical record documentation was reviewed for perioperative metrics, complications, pain, quality of life and satisfaction with the implant surgery. All 50 individuals were contacted at a minimum of 24 months follow-up (mean, 40 months); 45 individuals were evaluable and included in the analysis. A clinically significant improvement (a 2-point change from baseline) was observed in 7 of 9 domains of daily living. There were 10 perioperative complications, including implant penetration into the sacral neural foramen (n=2) and compression of the L5 nerve (n=1); these resolved with surgical retraction of the implant. Limitations of this study include its retrospective design, lack of a comparator group, small sample size, single surgeon experience, and a non-standard outcomes measure. Sachs and Capobianco (2012) retrospectively evaluated the medical records of the first 11 consecutive individuals treated with the iFuse Implant System. Perioperative metrics and baseline pain scores were recorded using a 0 to 10 numerical rating scale. The mean VAS score for pain was 7.9 at baseline and 2.3 at 12-month follow-up, representing a clinically and statistically significant (p=0.000) improvement. Limitations of this study include its retrospective design, lack of a comparator group, and very small sample size.

Sachs and Capobianco (2013) performed a second retrospective case review of the first 40 consecutive individuals with 1-year follow-up data that underwent minimally invasive sacroiliac joint fusion with the iFuse Implant System. Nearly one-half (48%) of the individuals had a history of previous lumbar spine surgery that included: fusion at one or more levels (63%), decompression (16%), discectomy (10.5%) and 10.5% with nonspecific documented procedures. Medical record documentation was reviewed for demographics, perioperative metrics, complications, pain scores, and satisfaction with the procedure. Postoperative complications included transient trochanteric bursitis (n=2, 5%), facet joint pain (n=8, 20%), and new low back pain (n=1, 2.5%). There were no reoperations at 1 year. The mean pain score improved from 8.7 (± 1.5) at baseline to 0.9 (± 1.6) at 12 months, a 7.8-point improvement (p<0.001). Two individuals went on to have fusion surgery for significant degenerative disc disease or spinal stenosis. Limitations of this study include its retrospective design, lack of a comparator group, small sample size, and heterogeneous group of subjects (in terms of prior lumbar spine surgery procedures).

Duhon and colleagues (2013) reported interim results of an ongoing industry-sponsored, multicenter, prospective, single-arm clinical trial evaluating the early safety and 6-month effectiveness of the iFuse Implant System to relieve pain and improve quality of life in individuals with degeneration or disruption of the sacroiliac joint who have failed non-surgical care. The safety cohort included 94 subjects at 23 sites with chronic sacroiliac joint pain who met study eligibility criteria and underwent minimally invasive sacroiliac joint fusion between August 2012 and September 2013. Subjects underwent structured assessments preoperatively, immediately postoperatively, and at 1, 3, and 6 months postoperatively, including sacroiliac joint and back pain VAS, ODI, SF-36, and EuroQoL-5D (EQ-5D). Satisfaction with surgery was also assessed at 6 months. Three implants were used in 80% of subjects; 2 subjects underwent staged bilateral implants. A total of 23 adverse events occurred within 1 month of surgery and 29 additional events occurred between 30 days and latest follow-up. Six adverse events were severe but none were device related. The effectiveness cohort included 32 subjects, but only 26 remained in the cohort with reportable 6-month outcomes. In this cohort, mean sacroiliac joint pain improved from a baseline score of 76 (± 16.2) to a 6-month score of 29.3 (± 23.3, an improvement of 49 points, p<0.0001), mean ODI improved from 55.3 (± 10.7) to 38.9 (± 18.5, an improvement of 15.8 points; p<0.0001) and SF-36 PCS improved from 30.7 (± 4.3) to 37.0 (± 10.7, an improvement of 6.7 points; p=0.003). A total of 90% of subjects who were ambulatory at baseline regained full ambulation by month 6; median time to full ambulation was 30 days. Satisfaction with the procedure was high at 85%. Limitations of this trial include lack of an active control group and use of a non-standard outcome measure (that is, ODI) which is designed to evaluate lower back pain and not sacroiliac joint pain. Study enrollment is continuing and further results with long-term follow-up are needed.

Smith and colleagues (2013) conducted an industry-sponsored multicenter, retrospective comparative cohort study of 263 individuals who underwent sacroiliac joint fusion using either an open surgical technique with a combination of screws and cages or a minimally invasive surgical technique with the iFuse Implant System. Data extracted from medical records included demographics, history of prior lumbar spinal fusion, length of hospital stay (LOS), and both preoperative and 12- and 24-month postoperative pain score. Improvements in pain were compared after matching for age and gender and controlling for a history of lumbar spine fusion using repeated measures analysis of variance. Data were available for 149 individuals treated with open surgery and 114 treated with the iFuse Implant System. Pain relief, measured as change from baseline to 12 months in VAS pain rating, was 3.5 points lower in the iFuse implant group versus the open surgery group (-6.2 vs. -2.7 points; p<0.001). When matched for age, gender and a history of prior lumbar spinal fusion, postoperative pain scores were on average 3.0 points (95% confidence interval [CI], 2.1-4.0) lower in the iFuse implant group versus the open surgery group (rANOVA , p<0.001). Postoperative complications were slightly more common in the open surgery group (21% of subjects) compared to the iFuse implant group (18% of subjects). The most common complications reported in both groups were postoperative neuropathy (n=4, open surgery) and transient trochanteric bursitis (n=2, iFuse implant group). Limitations of this trial include its retrospective design, lack of a randomized control group and participant-reported outcomes (such as ODI, short-form health questionnaires) and not all sites had complete data sets for some outcome measures.

Additional case series have been published in the peer-reviewed literature. In an industry-sponsored multicenter retrospective study, Sachs and colleagues (2014) reported on a “patient-level analysis” of 144 consecutive individuals with a mean of 16 months postoperative follow-up from six sites. The analysis did not include information on the total number of participants who were treated during the same time interval. The mean baseline pain score was 8.6. At a mean follow-up of 16 months, the VAS score was 2.7 on a scale of 0-10, an improvement of 6.1 points (mean, 5.6-6.6); however, 10% of participants reported an improvement of 1 point or less. Substantial clinical benefit, defined as a decrease in pain by > 2.5 points, or a score of 3.5 or less, was achieved in 91.9% of participants. Limitations of this analysis include the retrospective design from a patient-level analysis, no comparator group, and follow-up of only 16 months. Rudolf and Capobianco (2014) described 5-year clinical and radiographic outcomes after minimally invasive sacroiliac joint fusion using the iFuse Implant System in 17 of 21 evaluable individuals treated at their institution. A total of 88.2 % of participants had substantial clinical benefit, defined as a 2.5-point decrease or a raw score < 3.5. The mean ODI score at 5 years was 21.5. Imaging by radiograph and computed tomography showed intra-articular bridging in 87% of participants with no evidence of implant loosening or migration. Limitations of this industry-sponsored retrospective review include the small sample size, lack of participant-reported outcomes (such as ODI and SF-36) and no comparator group.

Cher and colleagues (2015) reported rates of implant revision from data collected between April 2009 and July 2014 on minimally invasive sacroiliac joint fusion procedures using the iFuse Implant System. Data was combined from a company-maintained inventory management and complaints databases collected during postmarket surveillance to estimate the revision rates, comparing those observed in the commercial setting to those reported in two ongoing prospective clinical trials (NCT01681004 and NCT01640353), as well as to rates reported with other orthopedic implants. A total of 11,416 cases were implanted with the iFuse Implant System. The cumulative revision rate at 4 years was 3.54%, considering adjustments of numbers to account for non-recommended uses and inability to match revision cases. Of the revision surgeries, 24% occurred in the first month and 63% occurred within the first 12 months. One-year revision rates decreased from 9.7% to 1.4% from 2009 to 2014. Schoell and colleagues (2016) retrospectively analyzed postoperative complications tracked in an administrative database of minimally invasive sacroiliac joint fusion procedures to identify complications as coded in postoperative insurance claims. Using ICD-9 codes corresponding to a surgical complication within 90 days or 6 months (if the codes were used for the first time), the overall incidence of complication in 469 individuals was 13.2% at 90 days and 16.4% at 6 months. The infection rate was 3.6% at 90 days and the rate of complications classified as nervous system complications was 4.3%. The authors noted that the rate of infection was higher than those reported for other types of minimally invasive spine procedures; however, determining an accurate incidence of adverse events after any procedure from registries or insurance claims data can be difficult as there is uncertainty concerning the accuracy of coded claims in the database and completeness of reporting in patient registries.  

Whang and colleagues (2015) completed a comparison of surgical and non-surgical treatments for sacroiliac joint fusion in individuals who had failed nonoperative care for chronic sacroiliac joint dysfunction. The investigators conducted an industry-sponsored non-blinded randomized controlled trial (INSITE, Investigation of Sacroiliac Fusion Treatment) of the iFuse Implant System in 148 subjects with sacroiliac joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions. Participants were included based on identification of the sacroiliac joint as the pain generator from a combination of a history of sacroiliac joint-localized pain, positive provocative testing on at least 3 of 5 established physical tests, and at least a 50% decrease in sacroiliac joint pain after image-guided local anesthetic injection into the joint. The duration of pain before enrollment averaged 6.4 years (range, 0.47-40.7 years). Prior treatments in the control group included physical therapy (78.3% of subjects), intra-articular steroid injections (91.3%), and radiofrequency ablation (RFA) of the sacroiliac nerve roots (8.7%). Participants were assigned in a 2:1 ratio to minimally invasive sacroiliac joint fusion (n=102) or to nonsurgical management (NSM) (n=46). Participants randomized to NSM received treatment in a stepwise progression (depending on the participant’s needs) of pain medications, physical therapy (98%), intra-articular steroid injections (73.9%), and RFA of sacral nerve roots (45.7%). No cognitive behavioral therapy for sacroiliac joint pain treatment was used. The primary outcome measure was comparison of 6-month success rates using Bayesian methods and defined as the proportion of treated subjects with a 20-mm improvement in sacroiliac joint pain in the absence of severe device-related or neurologic adverse events or surgical revision. It was stated that 6-month follow-up data was obtained in 44 of 46 (95.7%) NSM participants and 100 of 102 (98%) surgery participants; 3 additional participants withdrew and 1 participant had insufficient follow-up. Missing values were considered to be treatment failures. Participants in the NSM group could crossover to surgery after 6 months. Baseline scores indicated that the participants were highly debilitated, with VAS pain scores averaging 82.3 of 100 and ODI scores averaging 61.9. At 6 months, success rates were 23.9% in the NSM group versus 81.4% in the surgical group (posterior probability of superiority >0.999). A ≥ 15-point ODI improvement at 6 months occurred in 27.3% of NSM participants compared with 75.0% in the surgical group. Measures of quality of life (including SF-36) also improved to a greater extent in the surgery group. Opioid use remained high in both groups (70.5% for NSM, 58.0% for fusion participants; p=0.082). A total of 181 adverse events were reported at the 6-month follow-up: 133 in the surgery group (21 events rated as “severe”) and 48 in the NSM group (6 events rated as “severe”); leg and pelvic pain were the most common adverse events. The mean number of events per subject was slightly higher in the surgery group (1.3 vs. 1.0 events; p=0.1857). While the investigators suggest these results are positive, there is a high potential for bias in a nonblinded study with subjective outcome measures. At the onset of the study, 10 participants withdrew after randomization (7 to surgery, 3 to control), two-thirds of the participants were female, and 37.8% of the participants had a history of prior lumbar fusion (for unclear indications), which may not be representative of the broader population of individuals with chronic low back pain. At 6 months, 83 of 102 surgery participants (81.4%) and only 11 of 46 NSM participants (23.9%) met the study’s primary success endpoint. As more than 75% (35 of 46) of NSM participants crossed over to surgical management, the ability to derive unbiased across-treatment comparison is limited after the 6-month visit. In addition, the short follow-up time of 6 months limits drawing conclusions concerning the durability of sacroiliac joint fusion to improve clinical outcomes (such as, pain control or a reduction in disability) and identify any long-term adverse complications.

Polly and colleagues (2015) reported 12-month outcomes on 44 participants (of the 46 participants initially randomized at the study onset) from the Whang (2015) INSITE trial who were still participating at 6 months; a total of 35 participants crossed over to sacroiliac joint fusion. Opioid use remained high in both groups at 6 months, reported as 70.5% for NSM participants compared to 58.0% for fusion participants (p=0.082), and at 12 months, 55% for NSM participants compared to 52% for fusion participants (p=0.61). Improvements in ODI at 12 months were sustained in the fusion group, with participants who crossed over reporting improvements in pain, ODI and quality of life similar to those in the original surgical group. Adverse events were more common in the surgical group compared to the NSM group at 6 months (1.3 vs.1.1 events per participant, respectively; p=0.31). At 12 months, adverse events in the surgical group and NSM group were reported as 1.8 versus 1.9 per participant, respectively; however, the NSM group included participants who underwent crossover to sacroiliac joint fusion surgery, making meaningful comparisons in the rate of adverse events at 12 months unclear. Although the 12-month outcomes were reported as favorable, without a sham control, there remains a potential for bias in this nonblinded study with subjective outcome measures. Other limitations of this report include short-term (12-month) follow-up, use of a nonsurgical comparator group, and lack of radiograph validation of fusion. The investigators plan to follow all participants through 24 months to further evaluate the safety and efficacy outcomes of sacroiliac joint fusion for select individuals with sacroiliac joint dysfunction.

Polly and colleagues (2016) reported 2-year outcomes from the randomized controlled trial (Polly, 2015; INSITE) of individuals treated with minimally invasive sacroiliac joint fusion for chronic sacroiliac joint dysfunction. Of the 102 participants originally treated with sacroiliac joint fusion, 89 (87%) were evaluated at 2 years. Although the clinical trial used a different composite endpoint, clinical outcomes in this report were based on the amount of improvement in sacroiliac joint pain and ODI scores. Improvement was defined as a change of 20 points in sacroiliac joint pain score and 15 points in ODI score. Substantial improvement was defined as a change of 25 points in sacroiliac joint pain score or a score of 35 or less and an improvement of 18.8 points in ODI score. At 24 months, 83.1% and 82% of participants had improvement and substantial improvement in sacroiliac joint pain score, and 68.2% and 65.9% had improvement and substantial improvement in ODI. In addition, the proportion of participants taking opioids was reduced from 68.6% at baseline to 48.3% (29.6% reduction; p=0.0108 for change). A total of 22 (23%) adverse events related to device or procedure occurred in the sacroiliac joint fusion group (n=102), including ipsilateral or contralateral sacroiliac joint pain and trochanteric bursitis (n=9), surgical wound problems (n=5), postoperative medical problems (n=4, including nausea/vomiting, urinary retention, and atrial fibrillation), iliac fracture (n=1), asymptomatic physical exam or radiographic findings (n=2), and neuropathic symptoms (n=1). Three participants assigned to sacroiliac joint fusion and 1 participant who underwent sacroiliac joint fusion as a crossover treatment underwent revision surgery within the 24-month follow-up period. Limitations of this study include lack of a sham comparator group and the high crossover rate to sacroiliac joint fusion at 6 months.

Sachs and colleagues (2016) retrospectively reported outcomes of 107 participants at a minimum follow-up of 3 years after minimally invasive transiliac sacroiliac joint fusion using the iFuse Implant System. This industry-sponsored study included participants treated at one center that was previously reported (Sachs, 2014). Participants completed questionnaires in the clinic, over the telephone, or by email regarding sacroiliac joint pain, activities related to sacroiliac joint dysfunction, and the ODI. At a mean follow-up time of 3.7 years, pain scores improved from a mean of 7.5 at baseline to 2.5. A moderate residual disability persisted at follow-up with a reported ODI score of 28.2. The overall satisfaction rate was 87.9% (that is, 67.3% very satisfied, 20.6% somewhat satisfied). Five participants (4.7%) required revision surgery. The validity of outcomes reported by this study, however, cannot be determined as the number of eligible participants was not reported, so the actual follow-up rate is unknown. Limitations of this study include, but are not limited to, the retrospective design, inability of investigators to make contact with participants or their refusal to participate (which may have biased the results), and lack of reported baseline ODI scores in most participants, which limited the study’s ability to determine per-patient improvements at follow-up.

Heiney and colleagues (2015) conducted an industry-sponsored systematic review and meta-analysis of published studies of minimally invasive sacroiliac joint fusion utilizing a lateral transarticular approach in individuals with symptoms attributed to sacroiliac joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions unresponsive to non-surgical treatment. A total of 18 articles met the inclusion criteria; however, after accounting for overlapping cohorts, 12 unique studies from four countries with a total of 432 subjects were reviewed. Ten distinct cohorts (n=368; including but not limited to, Al-Khayer , 2008; Cummings, 2013; Duhon, 2013; Rudolf, 2012; Rudolf, 2014; Sachs, 2014; Whang, 2015) used a series of iFuse implants and 2 cohorts (n=64) used a hollow modular anchorage screw packed with demineralized bone matrix. The ramon effects meta-analysis (RMA) mean (range) was 59 minutes (27-78 minutes) for procedure time, 36.9 cc (10-70 cc) for estimated blood loss and 1.7 days (range 0-7 days) for length of stay. The baseline RMA mean pain score for the iFuse implant subjects was 8.1 (7.8-8.4) and dropped by approximately 5.2 points (2.8 score; range, 2.4-3.2) at 6 months and approximately 5.3 points (2.7 score; range, 2.1-3.3) at 12 months, and a 24-month score of 2.0 (1.4-2.5). Significant heterogeneity was observed for the baseline, 12- and 36-month scores, but not the 6- or 24-month scores. ODI decreased by 31 points at 12 months (baseline score of 56.2 [51.0-61.5], 6-month score of 30.7 [21.8-39.6], and 12-month score of 25.1 [12.3-37.9]). Subject-reported quality of life measured on the SF-36 physical component score was not consistently reported across studies, so RMA methods were not utilized. Meta-analysis was not performed for adverse events due to variability in reporting across studies. Limitations of this review and meta-analysis include significant heterogeneity observed between the studies in operative measures and subject-reported outcomes, and a lack of high quality evidence, as only one level I randomized trial and three prospective studies were available for analysis.

Duhon and colleagues (2016a; 2016b) reported the 24-month results of the prospective, multicenter, single-arm, industry-sponsored clinical trial (SI-Bone, Inc., Sacroiliac Joint Fusion with iFuse Implant System [SIFI]; NCT01640353) at 26 United States (U.S.) sites involving 172 individuals with sacroiliac joint dysfunction who underwent minimally invasive sacroiliac joint fusion with the iFuse Implant System. At baseline, 69.8% of participants were women (mean age, 50.9 years) and all participants had sacroiliac joint pain for an average of 5.1 years prior to surgical treatment. To address the diagnostic challenge of selecting appropriate candidates for device implantation, the study investigators used a diagnostic algorithm that included the use of a confirmatory diagnostic sacroiliac joint block as “…recommended by multiple pain and anesthesia specialty societies.” The study also allowed for inclusion of individuals with prior lumbar fusion (44.2%) (and a history of concomitant spine and hip disease), as the investigators stated this “is known to be a risk factor for sacroiliac joint degeneration, possibly by increasing adjacent segment stresses.” Study outcomes were assessed preoperatively and at postoperative intervals (1, 3, 6, 12, 18, and 24 months) in measurements of sacroiliac joint pain (0-100 VAS ratings), ODI, SF-36, EQ-5D, participant satisfaction, and adverse events throughout follow-up. At 12 months, all participants underwent a high-resolution pelvic CT scan. The investigators reported that 10 participants withdrew prior to sacroiliac joint fusion and data from 12 subjects at a single site were excluded from the original 194 eligible participants due to persistent non-compliance with the study protocol. Two additional sites were terminated more than 1 year into the study for protocol noncompliance (n=3); and, during post-enrollment monitoring, another 21 participants were found to not meet all eligibility criteria. As these participants were already enrolled and treated, they were included in the final analyses. Concerning the primary outcome measures, sacroiliac joint pain improved (mean decrease) by 53.8 points (that is, 79.8 [12.8] at baseline to 26.0 [26.7] points) at 24 months (p<0.0001 for change from baseline). The mean ODI score decreased from 55.2 (11.5) points at baseline to 30.9 (20.5) points at 24 months (p<0.0001 for change from baseline). Analyses that included imputation of missing data using the last observation carried forward method showed only minimal differences in 24-month sacroiliac joint pain and ODI reductions resulting from missing data (-3.1 points [0-100 scale] for VAS sacroiliac joint pain and -1.6% for ODI [0-100% scale]). Quality of life (SF-36 and EQ-5D) improvements observed at 12 months were sustained at 24 months (EQ-5D improved by 0.27 points; p<0.0001). Opioid use for sacroiliac joint or low back pain decreased from 76.2% at baseline to 55.0% at 24 months (p<0.0001). A total of seven device-related adverse events were reported (n=4, definitely device-related; n=3, probably device-related); three events were noted to be severe. Neuropathic pain related to implant impingement on sacral nerve roots occurred in 3 participants and resolved with immediate repositioning of the implants. In 4 participants, sacroiliac joint or hip pain was attributed to the presence of an implant or bone growth around the implant. At the time of study publication, 8 participants (4.7%) underwent one or more sacroiliac joint revisions surgeries. Limitations of this study include the lack of a control group undergoing non-surgical treatment, and only 149 participants (86.6%) were available for assessment at the 24-month follow-up.

Sturesson and colleagues (2017) reported short-term outcomes from another industry-sponsored, nonblinded multicenter, randomized controlled trial (iFuse Implant System Minimally Invasive Arthrodesis [iMIA]; NCT01741025) of 103 individuals from nine European spine clinics implanted with the iFuse Implant System. Eligible participants were adults (21-70 years old) with chronic, disabling sacroiliac joint pain for greater than 6 months (or greater than 18 months for pregnancy-related pain). The diagnosis of the sacroiliac joint as the primary pain generator was based on three criteria: 1) pain was present at or close to the posterior superior iliac spine (PSIS) and individual could point with a single finger to the location of pain (Fortin Finger Test); 2) at least three positive findings on five provocative physical examination maneuvers for sacroiliac joint pain; and, 3) at least 50 % pain reduction on fluoroscopically guided injection of local anesthetic into the joint (sacroiliac joint block). Participants were also required to have a baseline ODI score of at least 30 % and a baseline VAS low back pain (VAS LBP) score of at least 50 (0-100 scale). The baseline mean VAS LBP score was slightly higher, but not significant in the sacroiliac joint fusion group than in the CM group (77.7 vs. 73.0; p=0.0606). Individuals were excluded from participation if their low back pain was due to other causes, such as autoimmune sacroiliitis, recent pelvic trauma, spine surgery in the last 12 months, diagnosed or suspected osteoporosis, or allergy to titanium. The investigators stated that both groups were similar across key demographic and clinical parameters. The mean pain duration for participants at study onset was 4.5 years. A total of 33% of participants had undergone prior lumbar fusion, 16.5% has prior radiofrequency ablation of the sacral nerve root lateral branches, and most participants had undergone prior sacroiliac joint steroid injections. The primary outcome was change in self-rated VAS LBP score at 6 months. Secondary endpoints included leg pain, disability using ODI, quality of life using EQ-5D, and sacroiliac joint function using active straight leg raise test (ASLR). Of 109 randomized participants, 6 withdrew before treatment. Participants randomized to the control group (conservative management [CM]) were treated according to the European guidelines for the diagnosis and management of pelvic girdle pain (Vleeming, 2008). CM consisted of optimization of medical therapy, individualized physical therapy (2 sessions per week for up to 8 weeks) that focused on mobilization and stabilization exercises for control and stability, and adequate information and reassurance of the participant as part of a multifactorial treatment. Cognitive behavioral therapy (CBT) was allowed as part of CM; however, CBT was not available at all sites. Interventional procedures (for example, sacroiliac joint steroid injections, RFA of lateral branches of sacral nerve roots) were not part of the CM protocol. All participants assigned to the iFuse group underwent the procedure, and follow-up at 6 months was in 49 of 51 participants in the control group (CM) and in all 52 participants in the iFuse group. At 6 months, VAS LBP scores improved by 43.3 points in the iFuse group and by 5.7 points in the control group (p<0.001). ODI scores improved by 25.5 points in the iFuse group and by 5.8 points in the control group (p<0.001, between groups). Quality of life outcomes showed a greater improvement in the iFuse group than in the control group. Changes in pain medication use were not reported. Limitations of this trial include lack of blinding to treatment and use of self-reported outcomes that were only assessed to 6 months.

Dengler and colleagues (2017) reported one-year outcomes from the iMIA clinical trial (Sturesson, 2017; NCT01741025) comparing CM with minimally invasive surgical treatment in individuals with chronic low back pain originating from the sacroiliac joint. At the 6-month visit, 21 participants in the CM group were reported as having little or no improvement in symptoms and crossed over to sacroiliac joint fusion. A total of 14 of the 25 (56%) remaining participants in the CM group had at least a 20-point improvement in VAS LBP score (22.4% of participants assigned to CM), suggesting that some participants may have benefitted from individualized physiotherapy. At 12 months follow-up, low back pain had improved by 42 points (SD=27.0) on the VAS LBP scale in the sacroiliac joint fusion group compared with 14 points (SD=33.4) in the CM group (treatment difference, 27.6 points; p<0.0001). The mean ODI scores improved by 25 points in the sacroiliac joint fusion group compared with 8.7 points in the CM group (p<0.0001). One participant had postoperative nerve impingement, 2 participants had recurrent pain attributed to possible device loosening, and 1 participant had postoperative hematoma in the sacroiliac joint fusion group. In the CM group, one crossover participant had recurrent pain requiring a revision surgery. Limitations of this study include the small sample size, lack of blinding to treatment, crossover to sacroiliac joint fusion at 6-months in non-responders to CM (thus preventing direct effect size calculation after the 6-month visit), and self-assessed, subjective outcome measures.

In a nonrandomized, retrospective study, Vanaclocha and colleagues (2018) compared 137 individuals with up to 6 years follow-up who were treated with either conservative management (CM; n=63), sacroiliac denervation to the L4 to S-3 spinal region (n=47), or minimally invasive sacroiliac joint fusion with iFuse implants (n=27) for sacroiliac joint pain in the lumbosacral area of 3 months or greater duration. Causes of sacroiliac joint pain varied, including degenerative arthritis (with or without prior lumbar fusion) or joint disruption related to prior trauma. CM treatment was described as counseling for smoking and weight control, physiotherapy regarding chronic pain behavior avoidance, and use of non-steroidal anti-inflammatory agents. Participants were offered intraarticular sacroiliac joint steroid injections within 6 months if CM failed to provide relief of pain or disability. Post-intervention follow-up at 1 month and every 6 months evaluated pain levels using a VAS score, ODI, pain medication use, and changes in work status; supplemental data was extracted from participant medical records. At 12 months, a total of 15 participants were lost to follow-up (CM group, 11; sacroiliac denervation group, 4). At 6-year follow-up, only 16 of 63 (25%) CM participants, 2 of 47 (4%) sacroiliac denervation participants, and 1 of 27 (34.7%) sacroiliac joint fusion participants were available for inclusion in the final data set analysis. Sacroiliac denervation participants experience immediate response with a reduction in pain following sacroiliac joint infiltration; however, at 6 months follow-up, sacroiliac joint pain returned. Participants in the CM group reported no improvement in pain (mean worsening of 1 point), disability (mean ODI worsening by 4 to 6 points), or long-term work status. At 6 months and later, the mean difference in pain improvement between the CM and sacroiliac joint fusion groups was approximately 6 points (repeated measures analysis of variance, p<0.001), and the difference between the sacroiliac denervation and sacroiliac joint fusion groups was approximately 4.5 points (p<0.001). No available participant in the CM group (34 of 63 participants) and sacroiliac denervation group (23 of 47 participants) had improvement in ODI of at least 15 points at year 4. The authors reported that all sacroiliac joint fusion participants showed at least a 15-point improvement at year 4 (p<0.001); however, this rate was reported on 15 of 27 (56%) participants treated with sacroiliac joint fusion with iFuse implants at study onset. Limitations of this study include the non-randomized retrospective design reporting subjective outcomes, demographic and clinical factors that differed for those participants treated with sacroiliac denervation and sacroiliac joint fusion (including delay in initiation of sacroiliac denervation procedures due to insurance coverage issues in Spain’s health system and inaccurate diagnosis and treatments, including surgical treatment, for alternative diagnoses), and, lack of 6-year follow-up in a significant number of study participants (mean follow-up time was 43, 39, and 41 months in the CM, sacroiliac denervation, and sacroiliac joint fusion groups, respectively).

Rappoport and colleagues (2017) reported an industry-sponsored prospective study of sacroiliac joint fusion in individuals who had failed nonoperative treatment, including medication, physical therapy, and therapeutic injections. The SI-LOK® Sacroiliac Joint Fixation System implant (Globus Medical, Inc., Audubon, PA), a novel hydroxyapatite-coated cylindrical threaded screw, was implanted in 32 individuals with a diagnosis of sacroiliac joint dysfunction. A total of three screws were implanted per participant combined with packing using autogenous bone grafting. Clinical assessments and radiographs were collected and evaluated at 3, 6, and 12 months postoperatively. The mean preoperative VAS back and leg pain scores decreased significantly by 12 months postoperatively (p<0.01). Mechanical stability was achieved in 93.3% (28 of 30) of participants, and all participants who were actively employed preoperatively returned to work within 3 months. Two participants who required revision surgery reported symptom improvement within 3 weeks and did not require subsequent surgery. Limitations of this study include the small sample size, lack of randomization and a comparator group, and short follow-up. The study investigators plan to follow participants through 24 months to determine longer-term outcomes.

A search of the ClinicalTrials.gov database has identified ongoing studies in various phases investigating the safety and effectiveness of minimally invasive or percutaneous implanted devices for sacroiliac joint fusion (U.S. National Institutes of Health [NIH], 2016). The purpose of an industry-sponsored clinical trial (Zyga Technology, Inc) titled Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System (NCT02074761) is to evaluate the SImmetry Sacroiliac Joint Fusion System for relief of sacroiliac joint pain symptoms. The estimated primary completion date was December 2017. The 5-year postoperative study of two multicenter prospective U.S. clinical trials, the LOIS: Long-Term Follow-Up in INSITE/SIFI (NCT02270203), will evaluate the long-term safety and effectiveness of sacroiliac joint fusion in the same individuals that had already undergone the procedure with the iFuse Implant System. The estimated primary completion date for this study is December 2019.

Additional peer-reviewed medical literature regarding sacroiliac joint fusion procedures for the treatment of chronic low back pain presumed to be primarily of sacroiliac joint etiology and other pain-related sacroiliac conditions consists of small case series, retrospective studies, and review articles reporting limited safety and efficacy data for sacroiliac joint fusion procedures for the treatment of pain-related sacroiliac conditions from all causes (Belanger, 2001; Berthelot, 2011; Buchowski, 2005; Cummings, 2013, Ebraheim, 2010; Rudolf, 2013; Sachs, 2012; Schutz and Grob, 2006; Zelle, 2005). From a database of persons treated with the iFuse Implant System, Miller and colleagues (2013) stated 204 of 5319 (3.8%) individuals treated with the iFuse device reported complaints of pain (n=119, 2.2%) related to nerve impingement (n=48, 0.9%) or recurrent SI joint pain (n=43, 0.8%). All other clinical complaints were rare (≤ 0.2%). A total of 96 revision surgeries were performed in 94 (1.8%) individuals at a median follow-up of 4 months (range, 0 to 30 months). Revisions were performed in the early postoperative period for treatment of a symptomatic malpositioned implant (n=46, 0.9%) or to correct an improperly sized implant in asymptomatic individuals (n=10, 0.2%). Other revisions in the late postoperative period were performed to treat symptom recurrence (n=34, 0.6%) or for continued pain of undetermined etiology (n=6, 0.1%). Clinical effectiveness outcomes were not assessed or included in this study.

Other Considerations

In a European guideline on the diagnosis and treatment of pelvic girdle pain, Vleeming and colleagues (2008) state “there is no evidence to recommend sacroiliac fusion” for the treatment of pelvic girdle pain; the “D” level of evidence to support this recommendation consists of small cohort studies of 2 to 77 participants with the results assessed by the authors as fair to excellent in 50% to 89% of the participants.

In 2015, the ISASS issued recommendations for coverage criteria for sacroiliac joint (SIJ) fusion, reiterating their 2014 policy statement. These recommendations were updated in a 2016 statement. The ISASS recommendations state that an individual may be eligible for minimally invasive SIJ fusion when all of the following criteria are met:

Minimally invasive SIJ fusion is NOT indicated for patients with the following:

Bilateral SIJ pain is not uncommon. Diagnosis of bilateral SI joint pain must be made on the basis of a history of bilateral pain, bilateral elicitation of pain on physical examination maneuvers that stress each SIJ, and acute bilateral decrease in pain upon fluoroscopically-guided intra-articular SI joint block with local anesthetic.

The North American Spine Society (NASS, 2015) has published coverage policy recommendations on percutaneous sacroiliac joint fusion. The recommendations state, “within the limits of a moderate body of evidence...percutaneous (also referred to as minimally invasive) SIJ fusion...is indicated for the treatment of SIJ pain for patients with low back/buttock pain who meet ALL of the following criteria”...:

  1. Have undergone and failed a minimum six months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ and hip including a home exercise program
  2. Patient’s report of typically unilateral pain that is caudal to the lumbar spine (L5 vertebrae), localized over the posterior SIJ, and consistent with SIJ pain
  3. A thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin’s point, i.e., at the insertion of the long dorsal ligament inferior or the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (e.g. greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist
  4. Positive response to a cluster of 3 provocative tests (e.g. thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test). Note that the thrust tests is not recommended in pregnant patients or those with connective tissue disorders
  5. Absence of generalized pain behavior (e.g. somatoform disorder) or generalized pain disorders (e.g. fibromyalgia)
  6. Diagnostic imaging studies that include ALL of the following:
    1. Imaging (plain radiographs and a CT or MRI) of the SI joint that excludes the presence of destructive lesions (e.g. tumor, infection) or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion
    2. Imaging of the pelvis (AP plain radiograph) to rule out concomitant hip pathology
    3. Imaging of the lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition that can be causing low back or buttock pain
    4. Imaging of the SI joint that indicates evidence of injury and/or degeneration
  7. At least 75 percent reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced SIJ injection on two separate occasions
  8. A trial of at least one therapeutic intra-articular SIJ injection (i.e. corticosteroid injection)

Percutaneous SIJ fusion for SIJ pain is NOT indicated in ANY of the following scenarios:

The NASS coverage policy also recommends:

Due to the relatively moderate evidence, it is particularly critical that inclusion criteria are scrutinized and patient selection is executed with vigilance. The procedure itself has proven to be relatively safe. There is a valid concern for bias in that the overwhelming majority of the data produced so far has been industry-sponsored and generally composed of case series. However there are some data on five-year outcomes that demonstrate sustained benefit that does not appear to degrade from 1 year to 5 year time-points. The committee will revisit the quality of forthcoming evidence as it is produced in re-evaluations of the indications and coverage of this procedure.

At this time, no evidence-based guidelines regarding minimally invasive or percutaneous sacroiliac joint fusion procedures are available from the American Association of Neurological Surgeons (AANS), American Academy of Orthopaedic Surgeons (AAOS), and the American Pain Society (APS).

A search of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database contains 438 injury reports for “sacroiliac joint fixation” devices (Product Code: OUR) from January 2010 through August 2016 which includes, but is not limited to, 355 events mentioning revision procedures, and others reporting malposition (n=188), radicular pain (n=32), impingement (n=24), and infection (n=14). The MAUDE data represents voluntary reports of adverse events involving medical devices “which may have malfunctioned or caused a death or serious injury.” The MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. The FDA website should be viewed for additional information on MAUDE events related to specific sacroiliac joint fixation devices by brand name.

Summary

The current evidence on sacroiliac joint fusion is insufficient to permit conclusions regarding the clinical effectiveness of the procedures, whether performed as an open or minimally invasive (percutaneous) surgical procedure, with or without bone grafts and other metal implant devices, for individuals who are unresponsive to or cannot tolerate other therapy for chronic low back pain presumed to be primarily of sacroiliac joint etiology and other pain-related sacroiliac conditions. The overall quality of the body of evidence is low to moderate as the majority of studies are retrospective or prospective and have limitations such as high rates of participant attrition, lack of controls, and inadequate follow-up times. Relevant outcomes are symptoms, functional status, quality of life measures, medication use, and treatment-related morbidity. Two nonblinded randomized controlled trials reported superior short-term results for sacroiliac joint fusion, however, there is potential for bias because of unblinded controls and because the trials used self-reported outcomes. A placebo effect cannot be ruled out  in most case studies which rely on participant-reported outcomes and lack objective follow-up measures. Reports from adverse effects monitoring, registries and administrative data raise uncertainty about net health benefits achievable in clinical practice. Prospective trials with standardized selection criteria that evaluate long-term outcomes through comparative studies are needed to confirm the role of sacroiliac joint fusion procedures in the management of individuals with back pain presumed to be primarily of sacroiliac joint etiology and other pain-related sacroiliac conditions refractory to conservative, nonsurgical management.

Sacral Insufficiency Fractures

There are currently no randomized, prospective controlled studies that evaluate the safety and efficacy of minimally invasive or percutaneous sacroiliac joint fusion procedures for sacral insufficiency fractures. The available peer-reviewed literature consists of small retrospective case series, including technical reports that describe surgical techniques using screws or other fixation devices (Lin, 2001; Tjardes, 2008; Tsiridis, 2007) and others that address procedures performed on cadavers or involve biomedical modeling and analysis.

Papanastassious and colleagues (2008) reported the preliminary results of a percutaneous modified technique of navigated sacroiliac fixation in a case series of 6 individuals with oncologic conditions and sacral insufficiency fractures. The surgical technique used multiple long screws per level that crossed both sacroiliac joints and bilateral iliac bones. The authors concluded that further investigation is needed to compare this technique with other treatment modalities in terms of pain control and performance status improvement in individuals with oncologic conditions and sacral insufficiency fractures. In a small case series (n=4) and systematic review, Vavken and Krepler (2008) suggested that sacral insufficiency fractures as a complication after lumbosacral fusions are predominantly a benign condition and, depending on the location, respond well to conservative management in the majority of cases. Kleinberg and colleagues (2008) retrospectively reviewed 9 cases of individuals with osteoporosis who developed sacral insufficiency fractures after segmental posterior lumbosacral fixation procedures. Two subjects underwent immediate fracture stabilization and fusion. The remaining 7 subjects were initially treated nonoperatively, 4 subjects with bracing for an average of 3.3 months after initiation of treatment. The authors suggest that lumbopelvic fixation is a useful salvage treatment modality for individuals who fail nonoperative treatment.

There is insufficient evidence in the peer-reviewed literature in the form of large, prospective studies to establish the safety and efficacy of sacroiliac joint fusion procedures for sacral insufficiency fracture.

Summary

At this time, no evidence-based guidelines regarding sacroiliac spinal fusion procedures are available from the American Association of Neurological Surgeons (AANS), American Academy of Orthopaedic Surgeons (AAOS), and the American Pain Society (APS).

There is insufficient evidence in the scientific literature to support the use of sacroiliac joint fusion in treating mechanical low back pain presumed to be primarily of sacroiliac joint etiology and sacral insufficiency fractures. Randomized, controlled trials comparing sacroiliac joint fusion to standard treatments are needed to determine the impact on health outcomes and long-term efficacy.

Background/Overview

The sacroiliac joint is a firm, small joint that lies at the junction of the spine and the pelvis. While most of the bones (vertebrae) of the spine are mobile, the sacrum is made up of five vertebrae that are fused together and do not move. The iliac bones are the two large bones that make up the pelvis. As a result, the sacroiliac joints connect the spine to the pelvis. The sacrum and the iliac bones are held together by a collection of strong ligaments. These joints are important in transferring the load of the upper body to the lower body, supporting the entire weight of the upper body when we are erect, which in turn results in stress to this weight-bearing area of the pelvis and spine.

Sacroiliac Joint Pain and other Pain-related Sacroiliac Conditions

Sacroiliac joint problems are referred to by varying terms, including sacroiliac joint dysfunction, sacroiliac joint inflammation, sacroiliac joint strain, and sacroiliac joint syndrome. Each of these terms refers to a condition that causes pain in the sacroiliac joint area from a variety of causes. Individuals often experience pain in the lower back and hips, but pain may also be present in the groin and thighs; this pain is often aggravated by any form of movement including sitting, lifting, running or walking. The etiology of sacroiliac joint inflammation and pain can be difficult to diagnose since the sacroiliac joint is not easily palpated or manipulated, radiographs or other imaging studies are often normal, and other conditions (for example, degenerative arthritis, lower back pain, sciatica) can cause similar symptoms.

Sacral Insufficiency Fractures

Sacral insufficiency fractures occur when the quality of the sacral bone has become inadequate to handle the stress of weight bearing. The bone has lost some of its supporting structure and becomes weak and fragile. Sacral insufficiency fractures are usually located parallel to the spine, most often in the ala or “wings” of the sacrum, just beside the sacroiliac joint. A transverse fracture may also be present that connects an insufficiency fracture when it occurs on both sides of the sacrum. Sacral insufficiency fractures are known to develop in older persons, particularly in women, due to the presence of osteoporosis (that is, a decrease in bone tissue and minerals such as calcium) without definite trauma history. Other risk factors that can weaken the bone include radiation to the pelvis (for example, oncologic conditions), steroid use, rheumatoid arthritis, hyperparathyroidism, anorexia nervosa, liver transplantation, osteopenia, Paget's disease, hip joint replacement, and prior lumbosacral fusion. Sacral insufficiency fractures can also occur in pregnant or breastfeeding women due to temporary osteoporosis. The exact prevalence of sacral insufficiency fractures is unknown and is often difficult to diagnose at an early stage because the condition presents with signs and symptoms similar to, and is often accompanied by, concurrent lower lumbar degenerative disease.

Sacroiliac Joint Fusion Procedures

Sacroiliac joint fusion, also referred to as arthrodesis, is a surgical technique that involves bony fusion of the sacroiliac joint for stabilization. Sacroiliac joint fusion may be performed as a minimally invasive procedure or as an open surgical procedure requiring a larger incision and subsequent increased recovery time. Percutaneous sacroiliac joint fusion is a minimally invasive approach in which instrumentation involving cages or screws, with or without bone graft, are placed percutaneously in order to achieve a fusion.

Smooth or threaded metallic bone fastener devices used in sacroiliac joint fusion procedures have received 510(k) clearance by the FDA as Class II devices. These devices include, but are not limited to, the FUSIO Screw Fuze System (K141106) (Folsom Metal Products, Inc., DBA Frontier Devices, Pelham, AL); iFuse Implant System/iFuse SI Fusion System (K131405/K110838) cleared by the FDA as substantially equivalent to a predicate device called the SI Joint Fusion System (K080398; K092375); Silex™ Sacroiliac Joint Fusion System (K123702) (X-spine Systems, Inc., Miamisburg, OH); SImmetry® Sacroiliac Joint Fusion System (Zyga Technology, Inc., Minneapolis, MN), (K110512); SI-LOK Sacroiliac Joint Fixation System (K112028) (Globus Medical, Inc., Audubon, PA); and the SI FIX-MSB Sacroiliac Joint Fusion System (K110472) (Medtronic Sofamor Danek, Inc., Memphis, TN). The device systems consist of cannulated implants or screw-like rods (with or without washers) made of metallic/titanium alloys, some plasma coated, available in various diameters and lengths. The devices are intended for surgical implantation within the bone to create fixation and promote bone fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Definitions

Anterior: The front surface of the body.

Arthrodesis: The surgical fixation of a joint to promote bone fusion; also called artificial ankylosis or syndesis.

Axial skeleton: In the human body, the bones of the body axis, including the skull, vertebral column, ribs, and sternum.

Minimally invasive procedure: A procedure that is carried out by entering the body through the skin or through a body cavity or anatomical opening, but with the smallest damage or disruption possible to these structures.

Percutaneous: Through the skin. A percutaneous surgical procedure is considered minimally invasive when performed with only a small incision (in contrast to an "open" surgical incision).

Posterior: The back or dorsal surface of the body.

Sacroiliac joint: The joint formed by the sacrum and ilium where they meet on either side of the lower back.

Spinal fusion: The surgical immobilization of two or more adjacent bones of the spinal column (vertebra). Multiple bones are fused or made to grow together to become one solid bone; also called spondylosyndesis.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Medically Necessary:

CPT

 

27280

Arthrodesis, open, sacroiliac joint, including obtaining bone graft, including instrumentation, when performed

ICD-10 Procedure

 

0SG704Z-0SG70ZZ

Fusion of right sacroiliac joint, open approach, [by device; includes codes 0SG704Z, 0SG707Z, 0SG70JZ, 0SG70KZ, 0SG70ZZ]

0SG804Z-0SG80ZZ

Fusion of left sacroiliac joint, open approach, [by device; includes codes 0SG804Z, 0SG807Z, 0SG80JZ, 0SG80KZ, 0SG80ZZ]

ICD-10 Diagnosis

 

C41.4

Malignant neoplasm of pelvic bones, sacrum, and coccyx

C79.51

Secondary malignant neoplasm of bone

D16.8

Benign neoplasm of pelvic bones, sacrum, and coccyx

D48.0

Neoplasm of uncertain behavior of bone and articular cartilage

D49.2

Neoplasm of unspecified behavior of bone, soft tissue, and skin

M40.00-M40.299

Kyphosis [when treatment involves multisegment instrumentation]

M41.00-M41.9

Scoliosis [when treatment involves multisegment instrumentation]

M46.28

Osteomyelitis of vertebra, sacral and sacrococcygeal region

M46.38

Infection of intervertebral disc (pyogenic), sacral and sacrococcygeal region

M89.751-M89.759

Major osseous defect, pelvic region and thigh [when specified as related to neoplasm or sepsis]

S32.810A-S32.811S

Multiple fractures of pelvis with disruption of pelvic ring

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met or for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

ICD-10 Diagnosis

 

 

All other diagnoses not listed above including, but not limited to, the following:

G89.4

Chronic pain syndrome

M53.2X8

Spinal instabilities sacral and sacrococcygeal region

M53.3

Sacrococcygeal disorders, not elsewhere classified

M54.40-M54.42

Lumbago with sciatica

M54.5

Low back pain

M80.00XA-M80.00XS

Age-related osteoporosis with current pathological fracture, unspecified site

M80.80XA-M80.80XS

Other osteoporosis with current pathological fracture, unspecified site

M81.0-M81.8

Osteoporosis without current pathological fracture

M84.350A-M84.350S

Stress fracture, pelvis

M84.454A-M84.454S

Pathological fracture, pelvis

M84.550A-M84.550S

Pathological fracture in neoplastic disease, pelvis

M84.650A-M84.650S

Pathological fracture in other disease, pelvis

M84.851-M84.859

Other disorders of continuity of bone, pelvic region and thigh

M85.851-M85.859

Other specified disorders of bone density and structure, thigh

M88.851-M88.859

Osteitis deformans of thigh

Z79.51-Z79.52

Long-term (current) use of steroids

When services are also Investigational and Not Medically Necessary:

CPT

 

27279

Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device

ICD-10 Procedure

 

0SG734Z-0SG74ZZ

Fusion of right sacroiliac joint, percutaneous or percutaneous endoscopic approach [by device; includes codes 0SG734Z, 0SG737Z, 0SG73JZ, 0SG73KZ, 0SG73ZZ, 0SG744Z, 0SG747Z, 0SG74JZ, 0SG74KZ, 0SG74ZZ]

0SG834Z-0SG84ZZ

Fusion of left sacroiliac joint, percutaneous or percutaneous endoscopic approach [by device; includes codes 0SG834Z, 0SG837Z, 0SG83JZ, 0SG83KZ, 0SG83ZZ, 0SG844Z, 0SG847Z, 0SG84JZ, 0SG84KZ, 0SG84ZZ]

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Al-Khayer A, Hegarty J, Hahn D, Grevitt MP. Percutaneous sacroiliac joint arthrodesis: a novel technique. J Spinal Disord Tech. 2008; 21(5):359-363.
  2. Ashman B, Norvell DC, Hermsmeyer JT. Chronic sacroiliac joint pain: fusion versus denervation as treatment options. Evid Based Spine Care J. 2010; 1(3):35-44.
  3. Belanger TA, Dall BE. Sacroiliac arthrodesis using a posterior midline fascial splitting approach and pedicle screw instrumentation: a new technique. J Spinal Disord. 2001; 14(2):118-124.
  4. Berthelot JM, Gouin F, Glemarec J, et al. Possible use of arthrodesis for intractable sacroiliitis in spondylarthropathy: report of two cases. Spine (Phila Pa 1976). 2001; 26(20):2297-2299.
  5. Buchowski JM, Kebaish KM, Sinkov V, et al. Functional and radiographic outcome of sacroiliac arthrodesis for the disorders of the sacroiliac joint. Spine J. 2005; 5(5):520-528.
  6. Cher DJ, Reckling WC, Capobianco RA. Implant survivorship analysis after minimally invasive sacroiliac joint fusion using the iFuse Implant System(®). Med Devices (Auckl). 2015; 8:485-492.
  7. Cummings J Jr, Capobianco RA. Minimally invasive sacroiliac joint fusion: one-year outcomes in 18 patients. Ann Surg Innov Res. 2013; 7(1):12.
  8. Davidson D, Letts M, Khoshhal K. Pelvic osteomyelitis in children: a comparison of decades from 1980-1989 with 1990-2001. J Pediatr Orthop. 2003; 23(4):514-521.
  9. Dengler JD, Kools D, Pflugmacher R, et al. 1-year results of a randomized controlled trial of conservative management vs. minimally invasive surgical treatment for sacroiliac joint pain. Pain Physician. 2017; 20(6):537-550.
  10. Duhon BS, Cher DJ, Wine KD, et al. Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study. Med Devices (Auckl). 2013; 6:219-229.
  11. Duhon BS, Cher DJ, Wine KD, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: a prospective study. Global Spine J. 2016a; 6(3):257-269. 
  12. Duhon BS, Bitan F, Lockstadt H, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: 2-year follow-up from a prospective multicenter trial. Int J Spine Surg. 2016b; 10:13.
  13. Ebraheim NA, Ramineni SK, Alla SR, Ebraheim M. Sacroiliac joint fusion with fibular bone graft in patients with failed percutaneous iliosacral screw fixation. J Trauma. 2010; 69(5):1226-1229.
  14. Gallia GL, Haque R, Garonzik I, et al. Spinal pelvic reconstruction after total sacrectomy for en bloc resection of a giant sacral chordoma. Technical note. J Neurosurg Spine. 2005; 3:501-506.
  15. Giannikas KA, Khan AM, Karski MT, Maxwell HA. Sacroiliac joint fusion for chronic pain: a simple technique avoiding the use of metalwork. Eur Spine J. 2004; 13(3):253-256.
  16. Giannoudis PV, Tsiridis E. A minimally-invasive technique for the treatment of pyogenic sacroiliitis. J Bone Joint Surg Br. 2007; 89(1):112-114.
  17. Griffin DR, Starr AJ, Reinert CM, et al. Vertically unstable pelvic fractures fixed with percutaneous iliosacral screws: does posterior injury pattern predict fixation failure? J Orthop Trauma. 2006; 20(1 Suppl):S30-S36.
  18. Heiney J, Capobianco R, Cher D. A systematic review of minimally invasive sacroiliac joint fusion utilizing a lateral transarticular technique. Int J Spine Surg. 2015; 9:40.
  19. Hsu JR, Bear RR, Dickson KF. Open reduction internal fixation of displaced sacral fractures: technique and results. Orthopedics. 2010; 33(10):730.
  20. Kasten MD, Rao LA, Priest B. Long-term results of iliac wing fixation below extensive fusions in ambulatory adult patients with spinal disorders. J Spinal Disord Tech. 2010; 23(7):e37-e42.
  21. Kibsgard TJ, Roise O, Stuge B. Pelvic joint fusion in patients with severe pelvic girdle pain - a prospective single-subject research design study. BMC Musculoskelet Disord. 2014; 15:85.
  22. Klineberg E, McHenry T, Bellabarba C, et al. Sacral insufficiency fractures caudal to instrumented posterior lumbosacral arthrodesis. Spine (Phila Pa 1976). 2008; 33(16):1806-1811.
  23. Lin J, Lachmann E, Nagler W. Sacral insufficiency fractures: a report of two cases and a review of the literature. J Womens Health Gend Based Med. 2001; 10(7):699-705.
  24. Miller LE, Reckling WC, Block JE. Analysis of postmarket complaints database for the iFuse SI Joint Fusion System®: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption. Med Devices (Auckl). 2013; 6:77-84.
  25. Newman CB, Keshavarzi S, Aryan HE. En bloc sacrectomy and reconstruction: technique modification for pelvic fixation. Surg Neurol. 2009; 72(6):752-756.
  26. Papanastassiou ID, Setzer M, Eleraky M, et al. Minimally invasive sacroiliac fixation in oncologic patients with sacral insufficiency fractures using a fluoroscopy-based navigation system. J Spinal Disord Tech. 2011; 24(2):76-82.
  27. Peng KT, Huang KC, Chen MC, et al. Percutaneous placement of iliosacral screws for unstable pelvic ring injuries: comparison between one and two C-arm fluoroscopic techniques. J Trauma. 2006; 60(3):602-608.
  28. Polly DW, Cher DJ, Wine KD, et al. Randomized controlled trial of minimally invasive sacroiliac joint fusion using triangular titanium implants vs nonsurgical management for sacroiliac joint dysfunction: 12-month outcomes. Neurosurgery. 2015; 77(5):674-691.
  29. Polly DW, Swofford J, Whang PG, et al. Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. non-surgical management for sacroiliac joint dysfunction. Int J Spine Surg. 2016; 10:28.
  30. Rappoport LH, Luna IY, Joshua G. Minimally invasive sacroiliac joint fusion using a novel hydroxyapatite-coated screw: preliminary 1-year clinical and radiographic results of a 2-year prospective study. World Neurosurg. 2017; 101:493-497.
  31. Rudolf L. MIS fusion of the SI joint: does prior lumbar spinal fusion affect patient outcomes? Open Orthop J. 2013; 7:163-168.
  32. Rudolf L. Sacroiliac joint arthrodesis-MIS technique with titanium implants: report of the first 50 patients and outcomes. Open Orthop J. 2012; 6:495-502.
  33. Rudolf L, Capobianco R. Five-year clinical and radiographic outcomes after minimally invasive sacroiliac joint fusion using triangular implants. Open Orthop J. 2014; 8:375-383.
  34. Rysavy M, Pavelka T, Khayarin M, Dzupa V. Iliosacral screw fixation of the unstable pelvic ring injuries. Acta Chir Orthop Traumatol Cech. 2010; 77(3):209-214.
  35. Sachs D, Capobianco R. Minimally invasive sacroiliac joint fusion: one-year outcomes in 40 patients. Adv Orthop. 2013; 2013:536128.
  36. Sachs D, Capobianco R. One year successful outcomes for novel sacroiliac joint arthrodesis system. Ann Surg Innov Res. 2012; 6(1):13.
  37. Sachs D, Capobianco R, Cher D, et al. One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis. Med Devices (Auckl). 2014; 7:299-304.
  38. Sachs D, Kovalsky D, Redmond A, et al. Durable intermediate-to long-term outcomes after minimally invasive transiliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). 2016; 9:213-222.
  39. Salehi SA, McCafferty RR, Karahalios D, Ondra SL. Neural function preservation and early mobilization after resection of metastatic sacral tumors and lumbosacropelvic junction reconstruction. Report of three cases. J Neurosurg. 2002; 97(1 Suppl):88-93.
  40. Sar C, Kilicoglu O. S1 pediculoiliac screw fixation in instabilities of the sacroiliac complex: biomechanical study and report of two cases. J Orthop Trauma. 2003; 17(4):262-270.
  41. Schoell K, Buser Z, Jakoi A, et al. Postoperative complications in patients undergoing minimally invasive sacroiliac fusion. Spine J. 2016; 16(11):1324-1332.
  42. Schutz U, Grob D. Poor outcome following bilateral sacroiliac joint fusion for degenerative sacroiliac joint syndrome. Acta Orthop Belg. 2006; 72(3):296-308.
  43. Schweitzer D, Zylberberg A, Cordova M, Gonzalez J. Closed reduction and iliosacral percutaneous fixation of unstable pelvic ring fractures. Injury. 2008; 39(8):869-874.
  44. Smith AG, Capobianco R, Cher D, et al. Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes. Ann Surg Innov Res. 2013; 7(1):14.
  45. Sturesson B, Kools D, Pflugmacher R, et al. Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management. Eur Spine J. 2017; 26(3):708-719.
  46. Tjardes T, Paffrath T, Baethis H, et al. Computer assisted percutaneous placement of augmented iliosacral screws: a reasonable alternative to sacroplasty. Spine (Phila Pa 1976). 2008; 33(13):1497-1500.
  47. Tsiridis E, Upadhyay N, Gamie Z, Giannoudis PV. Percutaneous screw fixation for sacral insufficiency fractures: a review of three cases. J Bone Joint Surg Br. 2007; 89(12):1650-1653.
  48. Tumialan LM, Mummaneni PV. Long-segment spinal fixation using pelvic screws. Neurosurgery. 2008; 63(3 Suppl):183-190.
  49. Vanaclocha V, Herrera JM, Saiz-Sapena N, et al. Minimally invasive sacroiliac joint fusion, radiofrequency denervation, and conservative management for sacroiliac joint pain: 6-year comparative case series. Neurosurgery. 2018; 82(1):48-55.
  50. Vavken P, Krepler P. Sacral fractures after multi-segmental lumbosacral fusion: a series of four cases and systematic review of literature. Eur Spine J. 2008; 17 (Suppl 2):S285-S290.
  51. Whang P, Cher D, Polly D, et al. Sacroiliac joint fusion using triangular titanium implants vs. non-surgical management: six-month outcomes from a prospective randomized controlled trial. Int J Spine Surg. 2015; 9:6.
  52. Wise CL, Dall BE. Minimally invasive sacroiliac arthrodesis: outcomes of a new technique. J Spinal Disord Tech. 2008; (8):579-584.
  53. Zelle BA, Gruen GS, Brown S, George S. Sacroiliac joint dysfunction: evaluation and management. Clin J Pain. 2005; 21(5):446-455.
  54. Zhang HY, Thongtrangan I, Balabhadra RS, et al. Surgical techniques for total sacrectomy and spinopelvic reconstruction. Neurosurg Focus. 2003; 15(2):E5.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). 2009; 34(10):1066-1077.
  2. International Society for the Advancement of Spinal Surgery (ISASS). Recommendations for Coverage Criteria for Sacroiliac Joint Fusion. 2015. Available at: http://www.isass.org/public_policy/2015-03-19-coverage-criteria-for-minimally-invasive-si-joint-fusion-2015.html. Accessed on January 3, 2018.
  3. International Society for Advancement of Spine Surgery (ISASS). ISASS Policy 2016 Update-Minimally Invasive Sacroiliac Joint Fusion. Available at: https://www.isass.org/public-policy/isass-policy-statement-minimally-invasive-sacroiliac-joint-fusion-july-2016/. Accessed on January 3, 2018.
  4. Lorio MP, Rashbaum R. ISASS policy statement – minimally invasive sacroiliac joint fusion. Int J Spine Surg. 2014; 8.
  5. North American Spine Society (NASS). NASS Coverage Policy Recommendations. Percutaneous Sacroiliac Joint Fusion. June 9, 2015. For additional information, visit the NASS website: https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx. Accessed on January 3, 2018.
  6. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. iFuse SI Fusion System Summary of Safety and Effectiveness. No. K110838. Rockville, MD: FDA. April 21, 2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K110838.pdf. Accessed on January 3, 2018.
  7. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. SImmetry™ Sacroiliac Joint Fusion System Summary of Safety and Effectiveness. No. K110512. Rockville, MD: FDA. March 23, 2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K110512.pdf. Accessed on January 3, 2018.
  8. U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) Database. Product code: OUR. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM. Accessed on January 3, 2018.
  9. Vleeming A, Albert HB, Ostgaard HC, et al. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008; 17(6):794-819.
Websites for Additional Information
  1. American Academy of Orthopaedic Surgeons (AAOS). Available at: http://www.aaos.org/. Accessed on January 3, 2018.
  2. American Association of Neurological Surgeons (AANS). Available at: http://www.aans.org/. Accessed on January 3, 2018.
  3. American Pain Society (APS). Available at: http://www.americanpainsociety.org/. Accessed on January 3, 2018.
  4. North American Spine Society (NASS). Available at: http://www.spine.org/Pages/Default.aspx. Accessed on January 3, 2018.
Index

Frontier FUSIO Screw Fuze System
iFuse Implant System
SI-FIX Sacroiliac Joint Fusion System
SI-LOK Sacroiliac Joint Fixation System
Silex Sacroiliac Joint Fusion System
SImmetry Sacroiliac Joint Fusion System

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 

Document History

Status

Date

Action

Reviewed

01/25/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale, Background, References, and Websites for Additional Information sections.

Revised

02/02/2017

MPTAC review. Updated formatting in Position Statement section. Revised MN statement C. for use of sacroiliac joint fusion procedures in individuals with severe traumatic injuries associated with pelvic ring “disruption (that is, fracture or dislocation).” Updated Rationale, References, and Websites for Additional Information sections.

Reviewed

08/04/2016

MPTAC review. Updated Rationale, Background, References, and Websites for Additional Information sections.

Reviewed

02/04/2016

MPTAC review. Updated Rationale, References, and Websites for Additional Information sections. Removed ICD-9 codes from Coding section.

Reviewed

08/06/2015

MPTAC review. Updated Rationale, References, and Websites for Additional Information sections.

Reviewed

02/05/2015

MPTAC review. Format changes throughout document. Updated Description, Background, Coding, References, Websites for Additional Information, and Index sections.

 

01/01/2015

Updated Coding section with 01/01/2015 CPT changes; removed 0334T deleted 12/31/2014.

 

09/23/2014

Updated Rationale to correct NASS acronym to represent the North American Spine Society. 

Reviewed

02/13/2014

MPTAC review. Updated Description, Rationale, Background, References, Websites for Additional Information, and Index sections.

 

07/01/2013

Updated Coding section with 07/01/2013 CPT changes.

Revised

02/14/2013

MPTAC review. Clarified medically necessary statement. Revised investigational and not medically necessary statement with separate statements addressing: 1) conditions that do not meet the medically necessary criteria, and 2) minimally invasive and percutaneous sacroiliac joint fusion procedures. Updated Rationale, Background, Coding, References, Web Sites for Additional Information, and Index.

Revised

02/16/2012

MPTAC review. Updated Description with a cross reference to SURG.00067. Added medically necessary Position Statements. Revised investigational and not medically necessary Position Statement. Updated Rationale, Background, Coding and References.

New

11/17/2011

MPTAC review. Initial document development.