![]() | Medical Policy |
Subject: Coblation® Therapies for Musculoskeletal Conditions | |
Document #: SURG.00088 | Publish Date: 09/27/2023 |
Status: Reviewed | Last Review Date: 08/10/2023 |
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.
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 |
No randomized controlled trials (RCTs) evaluating the efficacy of Coblation technology and related devices for treatment of joint or musculoskeletal soft tissue conditions have been published. The available studies are small case series reporting short-term outcomes (Pandolfi, 2021; Tasto, 2005; Weil, 2008). Weil and colleagues (2008) evaluated the effectiveness of a minimally invasive technique using bipolar radiofrequency in 10 individuals with recalcitrant plantar fasciitis who failed conservative care. A percutaneous microtenotomy was performed unilaterally with the TOPAZ MicroDebrider. Outcome measures included a visual analog scale (VAS) and the American Orthopaedic Foot & Ankle Society (AOFAS) Hindfoot and Midfoot Scale. At the 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 significant improvement was not observed in VAS scores at 6 months compared with the 1-year follow-up. Limitations of this study include the lack of a control group, very small sample size, and short-term follow-up.
A 2021 case series by Pandolfi and colleagues included 18 individuals with cervical discogenic pain that was not responsive to 3 months of conservative care. Individuals were treated with percutaneous disc compression using coblation technology. The mean VAS score was 7.9 (standard deviation [SD], 1.6) before the procedure, 2.5 (SD, 3.1) at the 3- to 4-month follow-up and 2.5 (SD, 2.5) at the 2-year follow-up. As with other case series, the study had a small sample size and lacked a comparison group.
Well-designed RCTs with appropriate controls 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 (FDA, 2006) and the Werewolf Coblation System and Coblation Halo Wand (FDA, 2019) as Class II electrosurgical cutting and coagulation devices. 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] |
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ICD-10 Diagnosis |
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| All musculoskeletal conditions |
References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
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
WEREWOLF Coblation 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 | 08/10/2023 | Medical Policy & Technology Assessment Committee (MPTAC) review. Updated References section. |
Reviewed | 08/11/2022 | MPTAC review. Updated References section. |
Reviewed | 08/12/2021 | MPTAC review. Updated Rationale, Background/Overview, References and Index sections. |
Reviewed | 08/13/2020 | MPTAC review. Updated References section. |
Reviewed | 08/22/2019 | MPTAC review. Updated Rationale and References sections. |
Reviewed | 11/08/2018 | MPTAC review. Updated Description, Rationale, and References sections. |
Reviewed | 01/25/2018 | 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 References 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. |
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