Medical Policy

 

Subject: Coblation® Therapies for Musculoskeletal Conditions
Document #: SURG.00088 Publish Date:    02/28/2018
Status: Reviewed Last Review Date:    01/25/2018

Description/Scope

This document addresses the use of Coblation for the treatment of musculoskeletal conditions involving the ankle and foot, elbow, hip, knee, shoulder, and wrist. Coblation (ArthroCare Corporation; Austin, TX) is a type of radiofrequency ablation referred to as cold or controlled ablation. Coblation devices direct radiofrequency energy, rupturing target tissue cells, and disintegrating molecules with minimal heat production. Coblation technology can be delivered by a variety of wands, hand pieces and stylette tips used at different anatomic sites. Coblation-based wands such as the TOPAZ® MicroDebrider (ArthroWands®, ArthroCare Corporation; Austin, TX) are indicated for debridement, decompression, and removal of soft tissue during minimally invasive arthoscopic procedures involving tendons in the ankle and foot, elbow, hip, knee, shoulder, and wrist.

Note: Please see the following documents for other proposed uses of Coblation technology or other related indications:

Position Statement

Investigational and Not Medically Necessary:

The use of Coblation technology is considered investigational and not medically necessary for the treatment of musculoskeletal conditions.

Rationale

There are no randomized controlled trials (RCTs) in the medical literature demonstrating the efficacy of Coblation technology and related devices for treatment of joint or musculoskeletal soft tissue conditions. The available studies are small case series reporting short-term outcomes (Tasto, 2005). In a small study by Weil and colleagues (2008), the effectiveness of a minimally invasive technique using bipolar radiofrequency was performed on 10 individuals with recalcitrant plantar fasciosis who failed conservative care. This study compared pre- and post-treatment outcomes. A percutaneous microtenotomy was performed unilaterally with the TOPAZ MicroDebrider. Outcome measures included visual analog scale (VAS), American Orthopaedic Foot & Ankle Society (AOFAS) Hindfoot and Midfoot Scale, and participant satisfaction assessment. At 1 year follow-up, participants demonstrated a statistically significant improvement in VAS and AOFAS midfoot scores compared with baseline values (p<0.0001); however, a similar significant improvement was not observed in VAS scores at 6 months compared with 1-year follow-up. The investigators stated that although participants continued to improve at 1 year, they may have reached maximal improvement at 6 months or before. Limitations of this study include the lack of an appropriate control group, very small sample size, and short-term follow-up. The investigators concluded that well-designed RCTs are needed to determine the true effects of this procedure.

A phase IV clinical study was identified in the clinicaltrials.gov database comparing pain relief (primary outcome measure) utilizing the TOPAZ MicroDebrider with Coblation during percutaneous fasciotomy (no incision) to standard surgical fasciotomy in the treatment of plantar fasciosis. The study has been completed; however, to date, the results are unpublished in the peer-reviewed medical literature.

Well-designed randomized studies with appropriate controls and large sample sizes reporting long-term outcomes are needed to demonstrate the safety and efficacy of Coblation technology compared with established methods of management of musculoskeletal conditions.

Background/Overview

Coblation (that is, cold ablation) is a form of bipolar radiofrequency energy technology in which the current does not pass directly into the tissue, thereby producing minimal thermal injury to surrounding tissues. The mechanism of action involves combining bipolar radiofrequency energy with a conductive solution such as gel or saline. An electrode wand device forms a vapor that subsequently breaks down, producing ions in a gas plasma layer. The formed reactive plasma particles are able to break molecular bonds within the targeted tissue. The ArthroCare Corporation has created Coblation devices for intraoperative use to assist with hemostasis in a number of surgical settings including cosmetic, urology, spine and neurology, ear, nose and throat, gynecology, and laparoscopy/general surgery.

The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to ArthroCare TOPAZ ArthroWands as a Class II arthroscope (HRX), electrosurgical cutting and coagulation devices (GEI) (FDA, 2006). Commercially available Coblation devices (ArthroCare Sports Medicine) include a broad range of surgical wands used by orthopedic surgeons to perform minimally invasive arthroscopic procedures to the ankle and foot, elbow, hip, knee, shoulder, and wrist, and may involve soft tissue debridement, subacromial decompression, meniscal removal and sculpting, or tendon debridement.

Definitions

Bipolar radiofrequency: A radiofrequency device that contains both the active and return electrodes in the probe.

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 Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

20999

Unlisted procedure, musculoskeletal system, general [No specific code for surgery using Coblation technology]

29999

Unlisted procedure, arthroscopy [when specified as surgery using Coblation technology]

 

 

ICD-10 Diagnosis

 

 

All musculoskeletal conditions

References

Peer Reviewed Publications:

  1. Khan AM, Fanton GS. Thermal energy in the knee. Techniques in Knee Surgery. 2004; 3(3):180-186.
  2. Levine MJ, Shaffer B. Basic science applications of thermal energy in arthroscopic surgery. Sports Med Arthro Rev. 2005; 13(4):186-192.
  3. Owens BD, Stickles BJ, Balikian P, Busconi BD. Prospective analysis of radiofrequency versus mechanical debridement of isolated patellar chondral lesions. Arthroscopy. 2002; 18(2):151-155.
  4. Sherk HH, Vangsness CT, Thabit G III, Jackson RW. Electromagnetic surgical devices in orthopaedics. Lasers and radiofrequency. J Bone Joint Surg Am. 2002; 84-A(4):675-681.
  5. Tasto JP, Cummings J, Medlock V, et al. Microtenotomy using a radiofrequency probe to treat lateral epicondylitis. Arthroscopy. 2005; 21(7):851-860.
  6. Weil L Jr, Glover JP, Weil LS Sr. A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis. Foot Ankle Spec. 2008; 1(1):13-18.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. ArthroCare® Topaz™ ArthroWands® Device Summary. No. K053567. Rockville, MD: FDA. March 6, 2006. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed on October 23, 2017.
Index

ArthroWand
Atlas System Controller
Bipolar Radiofrequency Electrosurgery
Cold Ablation
Non-Thermal Volumetric Tissue Reduction
TOPAZ EPF MicroDebrider 45
TOPAZ MicroDebrider with Integrated Finger Switches (IFS)
TOPAZ ICW
TOPAZ XL ICW

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 and References sections.

Reviewed

02/02/2017

MPTAC review. Updated References section.

Reviewed

02/04/2016

MPTAC review. Updated Rationale and References sections. Removed ICD-9 codes from Coding section.

Reviewed

02/05/2015

MPTAC review. Updated Description, Rationale, and Reference sections.

Reviewed

02/13/2014

MPTAC review. Updated Description, Rationale, References, and Index.

Reviewed

02/14/2013

MPTAC review. Updated Description, Rationale, Background, Coding, References, and Index.

Reviewed

02/16/2012

MPTAC review. Updated Description, Rationale, and References.

Reviewed

02/17/2011

MPTAC review. Updated Description, Coding, References, and Index.

Reviewed

02/25/2010

MPTAC review. Revised title to: Coblation® Therapies for Musculoskeletal Conditions. Updated Description, Background, Rationale, References, and Index.

Reviewed

02/26/2009

MPTAC review. Rationale and References updated.

Reviewed

02/21/2008

MPTAC review. Updated Rationale, Background, References, and Index. 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

03/08/2007

MPTAC review. References and Index updated.

New

03/23/2006

MPTAC initial document development.