Medical Policy



Subject: Hip Resurfacing
Document #: SURG.00051 Current Effective Date:    09/27/2017
Status: Reviewed Last Review Date:    08/03/2017

Description/Scope

This document addresses partial and total hip resurfacing procedures, which are used as an alternative to total hip replacement surgery.  In partial (hemi) hip resurfacing, a femoral shell is implanted over the femoral head to replace one side of the hip joint's articular surface.  In total hip resurfacing, a femoral shell is implanted over the femoral head and an acetabular shell is placed on the hip bone for the femur to fit into, thus "resurfacing" both sides of the hip joint.

Position Statement

Medically Necessary:

Partial Hip Resurfacing

Partial hip resurfacing of the femoral head, using a U.S. Food and Drug Administration (FDA) approved device, is considered medically necessary in individuals with osteonecrosis of the femoral head with subchondral collapse.

Total Hip Resurfacing

Total hip resurfacing arthroplasty (HRA), using an FDA-approved/cleared prosthesis, is considered medically necessary in fit, active individuals who:

  1. Have normal proximal femoral bone geometry and bone quality, and
  2. Would otherwise receive a conventional primary total hip replacement (THR), and
  3. Are likely to live longer than a current conventional THR prosthesis is expected to last.

Not Medically Necessary:

Partial or total hip resurfacing is considered not medically necessary when the criteria above have not been met.

Investigational and Not Medically Necessary:

Partial or total hip resurfacing is considered investigational and not medically necessary for all other indications not listed above.

Rationale

Hemi (partial) hip resurfacing of the femoral head is an established procedure for individuals with osteonecrosis of the femoral head.  In one case series of 33 hips, 91% of the devices were still implanted for a minimum of 5 years, with good or excellent results in 61%.  Another case series of 37 prostheses followed for 7 years reported that 9 failed, requiring revision, but that 24 of the remaining 28 implants continued to function well with excellent or good hip scores.  Several implant designs have been FDA approved for this purpose.

Total hip resurfacing has been proposed for instances when hemi hip resurfacing is insufficient, but total hip arthroplasty is considered inappropriate. At the present time, several total hip resurfacing devices have received Pre-Market Approval (PMA) from the FDA: the Birmingham Hip, the CONSERVE® Plus Total Resurfacing Hip System, and the Cormet Hip Resurfacing System.  Other devices, such as the Buechel-Pappas™ Integrated Total Hip Replacement, which have previously received FDA PMA for total hip replacement, have also been granted 510k clearance for use in hip resurfacing procedures.  The FDA's 510k clearance differs from PMA in that 510k clearance does not require the submission and rigorous review of clinical trial data prior to the subject device being cleared for use in the market.  Devices applying for 510k clearance need only prove that the subject device be substantially equivalent to a legally marketed device that is not subject to PMA.  A substantially equivalent device is marketed subject to the same regulatory controls as the device to which it is found to be substantially equivalent.  Manufacturers of devices that already have PMA, frequently seek 510k clearance for additional indications to expand the use of their devices.  The Buechel-Pappas device is one example of this practice, having receiving PMA for use in total hip replacement surgery and subsequent 510k clearance for use in total hip resurfacing.

Interest in newer total hip resurfacing devices using different designs has increased in the light of high failure rates reported on the polyethylene-on-metal (PoM) prostheses (Head, 1982; Treuting, 1997).  Standard hip resurfacing and replacement devices may use a metal femoral component and a polyethylene acetabular component.  Research into the reason for failure of hip prostheses has discovered that a frequent reason for device failure is related to polyethylene debris created by friction and wear between the polyethylene articulating surface against the surface of the metal femoral component.  This polyethylene debris collects in the joint space where it solicits an immune response.  The immune response is not effective against the polyethylene particles, so the body's defenses attack the bone adjacent to the prostheses, leading to bone loss and loosening of the implant (Beaule, 2002).  The problem of debris collection and subsequent immune response is potentially greater in hip resurfacing procedures because resurfacing procedures involve the use of a femoral component with a much greater surface area compared to that used in total hip replacement procedures.  It is proposed that this increase in surface area increases the volume of polyethylene debris in resurfacing procedures using PoM devices, thus increasing the likelihood of immune response and device failure.  The results of a recent case series study including 114 individuals who underwent PoM hip resurfacing procedures reported a device survival rate of 47% over a 10-year period.  The authors indicated that the survival of PoM hip resurfacing devices was deemed unacceptable (Duijsens, 2005).  Newer device designs have been proposed to replace the PoM devices including ceramic-on-polyethylene (CoP) devices with ceramic femoral component and polyethelyene acetabular component, ceramic-on-ceramic (CoC) devices where both components are made from ceramic materials, and metal-on-metal (MoM) prostheses where both components are made from metal.

Of these newer device types, there is published evidence addressing the safety and efficacy focuses on MoM devices.  This includes several small to medium sized randomized controlled trials (RCTs), a few case-control studies, and a handful of case series studies.  Vendittoli and colleagues (2006) report the results of an RCT comparing the 12-month outcomes of 102 individuals receiving MoM total hip replacement with 103 individuals receiving MoM total hip resurfacing procedures.  In their article they report no significant difference between the two groups on the WOMAC or Merle d'Aubigné-Postel scales.  They also report a significantly higher activity level and quicker return to heavy or moderate activities in individuals undergoing the resurfacing when compared to those receiving replacement.  Both techniques present similar complication rates of 15%.  Another controlled trial by Pollard and colleagues (2006) describes 5- to 7-year outcomes of two groups of 54 individuals each who received MoM total hip resurfacing or total hip replacement.  The authors report hip function was not significantly different between groups as measured by the Oxford hip score (OHS).  However, scores from the University of California at Los Angeles activity scale and EuroQol life score both found significantly better outcomes in the hip resurfacing group.  Revision rates were slightly lower in the resurfacing group (6% vs. 8%).  De Smet (2005) describes the results of a large case series study of 252 individuals receiving MoM total hip resurfacing procedures followed for 3-5 years.  The mean age of the study population was 49.7 years of age and the reported complication rate was 4.3% (n=11) and included sciatic nerve palsy (n=2) and heterotopic ossification Brooker grade 1 (n=3).  The report indicates that results on the Harris Hip and Merle d'Aubigné-Postel scales indicate early clinical success in this population of predominantly young, active people.  A study by the Canadian Arthroplasty Society (2013) of 2773 subjects who underwent total hip resurfacing and who were followed for a mean of 3.4 years indicates high prosthesis survival at 5 years (96.4%).  The results of these studies are promising and indicate that MoM total hip resurfacing is an acceptable alternative to total hip replacement in younger people where bone conservation is a consideration in preparation for later total hip replacement surgery.  However, it should be noted that not all devices provide the same outcomes.  Langton and colleagues reported on the incidence of adverse reactions related to metal debris in a large case series study of 4226 MoM total hip resurfacing procedures (2010).  Subjects received one of three different devices, two were the Birmingham and Conserve Plus devices available in the US, and the third was the Articular Surface Replacement (ASR; DePuy, Leeds, UK) which is not.  The authors report significant differences between devices with regard to prosthesis failure, with subjects receiving the ASR at much higher risk compared to the two other devices.  A retrospective cohort study involving 27,971 hip resurfacing procedures looked into the performance of different resurfacing devices (Jameson, 2012).  The results of this study indicate that five brands of prosthesis had a significantly greater risk of revision than the Birmingham Hip (ASR: hazard ratio (HR)=2.82, p<0.001; Conserve: HR=2.03, p<0.001; Cormet: HR=1.43; p=0.001; Durom: HR=1.67, p<0.001; Recap: HR=1.58, p=0.007).  Further research is needed to evaluate this issue.

Recent studies have focused on optimization of patient selection for hip resurfacing.  Langdon and others noted that individuals receiving smaller implants were at greater risk of failure (2010).  This was also found in more recent studies.  The Jameson study reported data indicating that women were at greater risk of revision than men (HR=1.30, p=0.007), but the risk of revision was independent of age (2012).  Additionally, they reported that smaller femoral head components were significantly more likely to require revision than medium or large heads (≤ 44 mm: HR=2.14; p<0.001, 45 to 47 mm: HR=1.48; p=0.001).  Operations performed by low volume surgeons were also associated with higher risk of revision (HR=1.36; p<0.001).  Similar data were reported by Smith and colleagues, who presented data from the National Joint Registry for England and Wales, a database with information on 31,932 resurfacing cases (2012).  They reported that at 5 years, women suffered greater risk of implant failure than men, irrespective of femoral head size (8.5% vs. 3.6%).  Additionally, those with smaller femoral heads also fared worse than those with larger femoral heads.  Multi-variate models for resurfacing procedures showed that head size was an independent predictor of revision for both men (p<0.0005) and women (p<0.0005).  

In the Canadian Arthroplasty Society study (2013) mentioned above, males were more likely to have higher 5-year overall prosthesis survival compared to females (97.4% vs. 93.6%).  Murray and colleagues published the results of a 10-year survival study of 554 subjects who were treated with the Birmingham hip (2012).  In the female cohort (n=267), the 10-year survival was 74%, with a 10-year revision rate for pseudotumor of 7%, a mean OHS of 43 (standard deviation [SD] 8), and a mean UCLA activity score of 6.4 (SD 2).  For the male cohort (n=379), 10-year survival was 95%, the 10-year revision rate for pseudotumor was 1.7%, the mean OHS was 45 (SD 6), and the mean UCLA score was 7.6 (SD 2).  In the most demanding subgroup, comprised of male subjects aged < 50 years, treated for primary osteoarthritis, the survival was 99% (95% confidence interval [CI], 97 to 100). 

Results of a systematic review reported by Haughom and others (2015) also reported that women demonstrated an increased likelihood of developing adverse local tissue reaction (odds ratio [OR], 5.70 [2.71-11.98]; p<0.001), dislocation (OR, 3.04 [1.2-7.5]; p=0.02), aseptic loosening (OR, 3.18 [2.21-4.58]; p<0.001), and revision (OR, 2.50 [2.25-2.78]; p<0.001) after primary MoM hip resurfacing arthroplasty.  The authors stated that although femoral head size has been frequently implicated as a prime factor in the higher rate of complication in women, further research is necessary to specifically probe this relationship.

Additional studies with long follow-up times have reiterated the findings that females are at higher risk of MoM hip resurfacing arthroplasty when compared to males (Halawi, 2017; Matharu, 2016; Seppänen, 2017).

Major concern has been increasing with regard to the development of metallosis due to a high rate of chromium, cobalt, and titanium ion release from MoM prostheses.  Several studies have demonstrated significantly high metal ion concentrations in whole blood and serum samples from individuals with MoM prostheses. Many of these studies have reported local soft tissue reactions to these high concentrations including aseptic lymphocytic vasculitis-associated lesion (ALVAL) and pseudotumor development (Isaac, 2009; Mahendra, 2009; Ollivere, 2009; Pandit, 2008; Smolders, 2011; Vendittoli, 2010).  To date, the available studies addressing this issue have been small or have had significant methodological issues, and it is not yet possible to predict which individuals will experience adverse events related to metallosis.  Additionally, the long-term result of elevated circulating blood metal ion concentrations is unknown.  These observations are reiterated in the American Academy of Orthopedic Surgeons technology review on MoM hip implants (2011).  Larger scale studies regarding MoM-related metallosis are needed to better understand this potential complication.  To this end, on May 6, 2012 the FDA notified the manufacturers of all available MoM hip implants that they are being required to conduct post marketing surveillance studies.  These studies are specifically required to provide data on the type and rates of adverse events, and serum and whole blood levels of chromium, and serum or blood levels of cobalt.  Metal ion levels must be collected at baseline and for each year the device is implanted for a minimum of 8 years. The FDA (2012) reports that these studies will:

…enable the agency to better understand these devices and their safety profiles related to metal on metal concentrations in the bloodstream...In an effort to determine their proper risk classification and how these devices should be regulated in the future.  A decision on the proper classification of metal on metal hip systems is forthcoming.

Several recent studies have been published addressing the long-term outcomes in subjects undergoing total hip resurfacing procedures.  Matharu (2013) reported on the long-term outcomes of 393 subjects who were less than 50 years of age and underwent hip resurfacing with the Birmingham device in 474 hips.  In this prospective case series study, all subjects were operated on by the same surgeon and followed for up to 14 years.  No loss to follow-up was reported.  A total of 16 (3.6%) implants underwent revisions at a mean of 6.2 years and no further surgical interventions were reported for any subject.  The cumulative survival rates of all implanted Birmingham devices was 96.3% at 10 years and 84.1% at 14 years.  The authors reported that females had a significantly increased risk of revision vs. males (p=0.047), and that decreasing femoral head size was associated with increased risk of revision (p=0.044).  Measurements on the OHS improved from a preoperative mean of 19.2 to 46.0 at the last postoperative follow-up.  Males had a significantly better median OHS score compared to females (3.1% vs. 6.3%; p=0.02).  Similar findings were reported with regard to the UCLA score, with males scoring significantly higher than females (7.0 vs. 5.0; p=0.01).  Radiographic studies at the last follow-up were available for 145 (45%) of the original cohort.  No changes in acetabular component inclination angle or the femoral shaft angle were noted.  Additionally, no evidence of osteolysis, loosening of components, or thinning of the femoral neck was reported.  This study demonstrates good long-term outcomes for subjects implanted with the Birmingham hip device.  However, this data must be viewed with the knowledge that all operations were conducted by a single surgeon in a specialty hospital with expertise in hip procedures.  Results in other circumstances may vary considerably from those reported in this study.

In 2014, the same group published the results of a similar prospective case series study of 180 subjects, 65 years of age and older who underwent implantation of the Birmingham hip device (Pailhe, 2014).  As with the study described above, all procedures were conducted by the same surgeon.  Follow-up was 10 years, with no subjects lost.  Revision arthroplasty was conducted in 3 subjects (1.7%).  One was the result of high impact trauma, and not related to implant failure or any associated complications.  Cumulative survival was 96.4% over the 10-year study period.  As was reported by Matharu, devices in males had a significantly higher cumulative survival rate of 98.8% vs. 91.9% for females.  The risk of revision increased with the subject age (HR=1.42; p=0.014).  Risk decreased with increasing femoral head size (HR=0.682 for each millimeter increase; p=0.024).  Revision risk was slightly decreased with male gender (HR=0.048), but was not significant for females (HR=4.079).  Median absolute OHS was 50% preoperatively vs. 4.4% postoperatively. OHS was significantly better postoperatively in males vs. females (2.1% vs. 6.3%; p=0.021).  Pelvic radiographs were available for 59% of all subjects not receiving revision surgery (105/177) at final follow-up.  No changes in acetabular component inclination angle or the femoral shaft angle were noted, and no loosening of the components was reported.  Asymptomatic heterotopic ossification was reported in 10 subjects (9.5%) and 3 cases of asymptomatic non-progressive femoral neck osteolysis were noted.  Data on blood metal concentrations were collected from 15 subjects at a mean of 4.9 years.  All samples were below recommended levels for chromium and cobalt.  As with the previously described study, the long-term safety and efficacy of the Birmingham hip appears to be established in this cohort.  However, the same cautions apply in the interpretation.

A study by Su et al. (2014) reported on the results of a prospective case series study of 265 subjects undergoing implantation of the Birmingham hip in 293 joints.  There were eight separate surgeons participating in the study.  At 2 years of follow-up, Harris Hip Scores improved significantly from a preoperative average of 56.8 to 96.9 postoperative (p<0.0001).  At 4 years, the postoperative score was 70.0, with 97.65% reporting good or excellent results.  Generic state of health measures were taken using the Euroqol-EQ-5D tool.  Out of a maximum 100 points, subjects had an average score of 70.6 preoperatively, 88.5 at 1 year postoperatively, and 87.6 at 2 years (p<0.0001).  Revision procedures were conducted for 7 subjects (2.4%) with the following complications: femoral neck fracture (n=2), pseudotumor reported (n=1), acetabular cup loosening (n=2), femoral implant loosening and femoral head osteonecrosis (n=1), and errant femoral implant placement (n=1).  No statistical significance was noted for implant survivorship between genders (p=0.062), but significant variation between gender subgroups with regard to femoral head size (44.7 mm for females vs. 50.8 for males; p<0.0001).  Heterotopic ossification was noted in 25.7% of radiographs at 2 years, but no osteolysis was reported.  Blood metal ion testing was reported at 1 year post-operation for 276 hips, with median whole blood cobalt levels of 1.15 parts per billion (ppb) and median whole blood chromium levels of 1.7 ppb.  At 4 years, blood metal ion data was available for 112 hips, with median whole blood cobalt levels of 1.56 parts per billion (ppb) and median whole blood chromium levels of 1.8 ppb.  Both of these measures were significant on the Wilcox-Mann-Whitney test (p<0.0002 for cobalt and p<0.00001 for chromium).  No significant differences were noted with regard to gender subgroups or to metal ion measurements.  The authors reported that 8 subjects were above the 7 ppb threshold for metal ion concentrations, with 6 subjects having both elevated cobalt and chromium levels.  In this high concentration subgroup, there was a significant gender difference, with 7.3% of females having metal ion levels greater than 7 ppb vs. 1% of males (p<0.0007).  An analysis indicated that female gender resulted in an Odds Ratio (OR) of 10.7 for increased risk of elevated metal ion concentrations compared to males.  However, none of the 8 subjects with elevated metal ion concentrations have undergone revision surgery and were asymptomatic at time of last follow-up.  This data further supports the long-term safety and efficacy of the Birmingham hip device.

These studies help demonstrate substantial safety and efficacy for the Birmingham hip device.  However, this data indicates significant differences with regard to outcomes for males vs. females, and for individuals with small femoral head sizes.  Interestingly, the two long-term studies with metal ion data do not find a relation to implant failure and metal ion concentrations.  Further research is warranted into these issues.

Background/Overview

Hip replacement surgery aims to re-establish functional joint movement and alleviate pain associated with hip damage due to degenerative joint disease or trauma.  Arthroplasty options for reconstruction of the hip include total hip replacement (THR), hemiarthroplasty (bipolar or unipolar), and partial or total hip resurfacing. 

In the standard total hip replacement operation, the femoral head and neck are removed, and the femoral canal (marrow space) is reamed-out.  The damaged hip joint is replaced with an artificial prosthesis composed of two or three different components: 1) the head, a metal ball (stainless steel or cobalt chrome) that replaces the original femoral head, 2) the femoral component (a metal stem placed into the femur) and 3) the acetabular component (a plastic cup made of high-density polyethylene) that is implanted into the acetabulum.  The stem may be secured using bone cement or press-fit for the bone to grow into it. 

In partial hip resurfacing, a femoral shell is implanted over the femoral head for avascular necrosis with collapse of the femoral head.  This method acts to preserve the bone stock of the acetabulum. 

In total hip resurfacing operations, the surgeon removes only the diseased or damaged surfaces of the head of the femur and the hip socket (acetabulum).  The femoral head is fitted with a spherical shell and the hip socket is lined with a thin spherical cup.  Both spherical cups form a pair of bearings which provide a low friction articulating surface.  Total hip resurfacing has been investigated in a broader range of individuals including those with osteoarthritis, rheumatoid arthritis, and advanced avascular necrosis.  It has been used as an alternative to total hip arthroplasty, particularly in young active individuals who would potentially outlive a total hip prosthesis.  Therefore, total hip resurfacing could be viewed as a time-buying procedure to delay the need for a total hip arthroplasty.

Advantages of total hip resurfacing compared to total hip arthroplasty include preservation of the femoral neck and femoral canal, thus facilitating revision or conversion to a total hip replacement, if required.  In addition, the resurfaced head is more similar in size to the normal femoral head, thus increasing the stability and decreasing the risk of dislocation compared to total hip arthroplasty.

At the present time many devices have received either PMA or 510K clearance from the FDA.  

Other surgical interventions used to alleviate the symptoms of degenerative joint disease of the hip include, but are not limited to, osteotomy, arthrodesis and arthroscopy of the hip joint.  Non-surgical interventions and medications can also be used to control these symptoms and delay or prevent the need for surgery.  Once non-operative modalities have failed, femoral head-preserving procedures including grafting techniques, core decompression with vascularized or non-vascularized bone grafting, and upper femoral osteotomies have all been used with varying success.

Definitions

Arthrodesis: Fusion of the femur to the pelvis; primarily indicated in children who have unilateral degenerative disease of the hip and are unresponsive to non-operative measures.

Arthroscopy: A minimally invasive surgical procedure used to investigate and treat traumatic and non-traumatic disorders of the hip. It is performed by means of an arthroscope introduced into the joint in order to visualize anatomical structures.

Osteotomy: The aim of osteotomy in dysplastic or osteonecrotic hips is to restore and realign the position of the joint by means of a fixation device.  For hips affected by osteonecrosis, the major goal of surgery is to move the necrotic segment away from the weight bearing area and restore blood supply to the necrotic zone.

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 may be Medically Necessary when criteria are met: 

CPT  
27299 Unlisted procedure, pelvis or hip joint [when specified as partial or total hip resurfacing]
   
HCPCS  
S2118 Metal-on-metal total hip resurfacing, including acetabular and femoral components
   
ICD-10 Procedure  
0SU90BZ Supplement right hip joint with resurfacing device, open approach
0SUB0BZ Supplement left hip joint with resurfacing device, open approach
0SUR0BZ Supplement right hip joint, femoral surface with resurfacing device, open approach
0SUS0BZ Supplement left hip joint, femoral surface with resurfacing device, open approach
   
ICD-10 Diagnosis  
  All diagnoses

When Services are Not Medically Necessary:
For partial or total hip resurfacing when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as not medically necessary.

When Services are Investigational and Not Medically Necessary:
For partial or total hip resurfacing when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

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  40. Nelson CL, Walz BH, Gruenwald JM. Resurfacing of only the femoral head for osteonecrosis. Long-term follow-up study. J Arthroplasty. 1997; 12(7):736-740.
  41. Ollivere B, Darrah C, Barker T, et al. Early clinical failure of the Birmingham metal-on-metal hip resurfacing is associated with metallosis and soft-tissue necrosis. J Bone Joint Surg Br. 2009; 91(8):1025-1030.
  42. Pailhe R, Matharu GS, Sharma A, et al. Survival and functional outcome of the Birmingham Hip Resurfacing system in patients aged 65 and older at up to ten years of follow-up. Int Orthop. 2014; 38(6):1139-1145.
  43. Pandit H, Glyn-Jones S, McLardy-Smith P, et al. Pseudotumours associated with metal-on-metal hip resurfacings. J Bone Joint Surg Br. 2008; 90(7):847-851. 
  44. Pollard TC, Baker RP, Eastaugh-Waring SJ, Bannister GC. Treatment of the young active patient with osteoarthritis of the hip. A five- to seven-year comparison of hybrid total hip arthroplasty and metal-on-metal resurfacing. J Bone Joint Surg Br. 2006; 88(5):592-600. 
  45. Schmalzried TP, Fowble VA, Ure KJ, Amstutz HC. Metal on metal surface replacement of the hip. Technique, fixation and early results. Clin Orthop Relat Res. 1996; (329 Suppl):S106-114.
  46. Seppänen M, Karvonen M, Virolainen P, et al. Poor 10-year survivorship of hip resurfacing arthroplasty. Acta Orthop. 2016; 87(6):554-559.
  47. Siguier T, Siguier M, Judet T, et al. Partial resurfacing arthroplasty of the femoral head in avascular necrosis. Methods, indications, and results. Clin Orthop Relat Res. 2001; (386):85-92.
  48. Silva M, Lee KH, Heisel C, et al. The biomechanical results of total hip resurfacing arthroplasty. J Bone Joint Surg Am. 2004; 86-A(1):40-46.
  49. Smith AJ, Dieppe P, Howard PW, Blom AW; National Joint Registry for England and Wales. Failure rates of metal-on-metal hip resurfacings: analysis of data from the National Joint Registry for England and Wales. Lancet. 2012; 380(9855):1759-1766.
  50. Smith TO, Nichols R, Donell ST, Hing CB. The clinical and radiological outcomes of hip resurfacing versus total hip arthroplasty: a meta-analysis and systematic review. Acta Orthop. 2010; 81(6):684-695.
  51. Smolders JM, Hol A, Rijnberg WJ, van Susante JL. Metal ion levels and functional results after either resurfacing hip arthroplasty or conventional metal-on-metal hip arthroplasty. Acta Orthop. 2011; 82(5):559-566.
  52. Stulberg BN, Trier KK, Naughton M, Zadzilka JD. Results and lessons learned from a United States hip resurfacing investigational device exemption trial. J Bone Joint Surg Am. 2008; 90 Suppl 3:21-26.
  53. Su EP, Housman LR, Masonis JL, et al. Five year results of the first US FDA-approved hip resurfacing device. J Arthroplasty. 2014; 29(8):1571-1575.
  54. Treacy RB, McBryde CW, Pynsent PB. Birmingham hip resurfacing arthroplasty. A minimum follow-up of five years. J Bone Joint Surg Br. 2005; 87(2):167-170. 
  55. Treuting RJ, Waldman D, Hooten J, et al. Prohibitive failure rate of the total articular replacement arthroplasty at five to ten years. Am J Orthop. 1997; 26(2):114-118.
  56. Vendittoli PA, Lavigne M, Girard J, Roy AG. A randomised study comparing resection of acetabular bone at resurfacing and total hip replacement. J Bone Joint Surg Br. 2006; 88(8):997-1002.
  57. Vendittoli PA, Lavigne M, Roy AG, Lusignan D. A prospective randomized clinical trial comparing metal-on-metal total hip arthroplasty and metal-on-metal total hip resurfacing in patients less than 65 years old. Hip Int. 2006; 16 Suppl 4:73-81.
  58. Vendittoli PA, Roy A, Mottard S, et al. Metal ion release from bearing wear and corrosion with 28 mm and large-diameter metal-on-metal bearing articulations: a follow-up study. J Bone Joint Surg Br. 2010; 92(1):12-19. 

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Agency for Healthcare Research and quality. Horizon Scan on Hip Replacement Surgery. December 22, 2006.
  2. Blue Cross Blue Shield Association. Metal-on-metal total hip resurfacing. TEC Assessment. 2007. 22(3).
  3. Bozic KJ, Browne J, Danhgles CJ, et al. Modern metal-on-metal hip implants: a technology overview.  J Am Acad Orthop Surg June 2012; 20(6):402-406.
  4. Lombardi AV Jr, Barrack RL, Berend KR, et al. The Hip Society: algorithmic approach to diagnosis and management of metal-on-metal arthroplasty J Bone Joint Surg Br. 2012; 94(11 Suppl A):14-18.
  5. U.S. Food and Drug Administration. Concerns about Metal-on-Metal Hip Implant Systems. Updated on January 17, 2013. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm. Accessed on May 30, 2017.
  6. U.S. Food and Drug Administration. FDA Activities. Updated on 02/17/2016. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241769.htm. Accessed on May 30, 2017.
  7. U.S. Food and Drug Administration. FDA Safety Communication: Metal-on-Metal Hip Implants. 2013. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm. Accessed May 30, 2017.
Index

Birmingham Hip Resurfacing (BHR) System
Buechel-Pappas Integrated Total Hip Replacement
Conserve Plus
Cormet 2000™
Cormet Hip Resurfacing 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 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale and References sections.
Reviewed 08/04/2016 MPTAC review. Updated Rationale and Reference sections. Removed ICD-9 codes from Coding section.
Reviewed 08/06/2015 MPTAC review. Updated Rationale and Reference sections.
Reviewed 08/14/2014 MPTAC review. Updated Description/Scope, Rationale and Reference sections.
Reviewed 08/08/2013 MPTAC review. Updated Rationale and Reference sections.
Revised 08/09/2012 MPTAC review. Deleted requirement in MN section for hip resurfacing devices that the devices be metal-on-metal. Updated Rationale section.
Reviewed 08/18/2011 MPTAC review. Updated Rationale section.
Reviewed 08/19/2010 MPTAC review. Updated Coding and Reference sections.
Reviewed 08/27/2009 MPTAC review.
  02/09/2009 Minor clarification to position statement made regarding type of hip resurfacing, total vs. partial.
Revised 08/28/2008 MPTAC review. Added not medically necessary statement. Updated Coding section with 10/01/2008 HCPCS changes.
  02/21/2008 The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Reviewed 08/23/2007 MPTAC review. Revised Rationale, Background and Index sections.
  06/12/2007 Coding updated. 
Revised 09/14/2006 MPTAC revised. Added metal-on-metal total hip resurfacing as medically necessary when criteria are met. Updated Rationale and Reference sections.
Reviewed 03/23/2006 MPTAC review. Updated references.
Revised 04/28/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
     
Pre-Merger Organization Last Review Date Document Number Title
Anthem, Inc. 04/27/2004 SURG.00051 Hip Resurfacing
WellPoint Health Networks, Inc. 06/24/2004 3.07.02 Hip Resurfacing