Thermal Capsulorrhaphy as a Treatment of Joint Instability

POLICY NUMBER

L.7.01.429

DESCRIPTION

Thermal capsulorrhaphy uses thermal energy to restructure collagen in the capsule or ligaments to reduce the capsule size. This procedure has primarily been evaluated for shoulder joint instability but may also be proposed to treat capsular laxity in other joints.

Shoulder instability is a relative common occurrence, reported in between 2% and 8% of the population. The condition may arise from a single traumatic event (i.e., subluxation or dislocation), repeated microtrauma or constitutional ligamentous laxity, resulting in deformation and/or damage in the glenohumeral capsule and ligaments. Shoulder instability may be categorized according to the movement of the humeral head, i.e., either as anterior, posterior, inferior, or multidirectional instability. Multidirectional instability most frequently consists of anterior and inferior subluxation or dislocation. Inferior movement is also classified as multidirectional.

Initial treatment of shoulder subluxation or dislocation is conservative in nature followed by range-of-motion and strengthening exercises. However, if instability persists, either activity modifications or surgical treatment may be considered. Activity modification may be appropriate for patients who can identify a single motion that aggravates instability, such as overhead throwing motions. Surgical treatment may be considered in those who are unwilling to give up specific activities (i.e., related to sports) or when instability occurs frequently or during daily activities.

Surgery consists of inspection of the shoulder joint with repair, reattachment, or tightening of the labrum, ligaments, or capsule performed either with sutures or sutures attached to absorbable tacks or anchors. While arthroscopic approaches have been investigated over the past decade, their degree of success has been controversial due to a higher rate of recurrent instability compared with open techniques, thought to be related in part to the lack of restoration of capsular tension. Recent reports of arthroscopic techniques have described various suturing techniques for tightening the capsule, which require mastery of technically difficult arthroscopic intra-articular knot tying.

Thermal capsulorrhaphy has been proposed as a technically simpler arthroscopic technique for tightening the capsule and ligaments. The technique is based on the observation that the use of nonablative levels of radiofrequency thermal energy can alter the collagen in the glenohumeral ligaments and/or capsule, resulting in their shrinkage and a decrease in capsular volume, both thought to restore capsular tension. Thermal capsulorrhaphy may be used in conjunction with arthroscopic repair of torn ligaments or other structures (i.e., repair of Bankart or superior labrum anterior and posterior lesion). In addition, thermal capsulorrhaphy has also been investigated as an arthroscopic treatment of glenohumeral laxity, a common injury among overhead athletes, such as baseball players, resulting in internal impingement of the posterior rotator cuff against the glenoid labrum. Internal impingement is often accompanied by posterior rotator cuff tearing and labral injury. Thermal capsulorrhaphy has also been proposed as a sole arthroscopic treatment. For example, the technique may be considered in patients with chronic shoulder pain without recognized instability, based on the theory that the pain may be related to occult or microinstability. This diagnosis may be considered when a diagnostic arthroscopy reveals only lax ligaments and is commonly seen among baseball players. Finally, thermal capsulorrhaphy may be considered in patients with congenital ligamentous laxity, such as Ehlers-Danlos or Marfan's syndrome.

While thermal capsulorrhaphy was initially investigated using laser energy, the use of radiofrequency probes are now more commonly used. Devices include Oratec® ORA-50 Monopolar RF Generator (Oratec Interventions, Menlo Park, CA) and ArthroCare® (ArthroCare, Sunnyvale, CA).

POLICY

Thermal capsulorrhaphy is considered not medically necessary as a treatment of joint instability, including, but not limited to the shoulder, knee, and elbow.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/2003: Approved by Medical Policy Advisory Committee (MPAC)

1/21/2004: Code Reference section completed

7/10/2009: Policy reviewed, no changes

08/12/2010: Policy statement changed from investigational to not medically necessary. FEP verbiage added to the Policy Exceptions section.

08/02/2011: Policy reviewed; no changes.

07/17/2012: Policy reviewed; no changes.

10/14/2013: Policy reviewed; no changes.

08/08/2014: Policy reviewed; description updated. Policy statement unchanged.

08/27/2015: Code Reference section updated to add ICD-10 codes.

10/30/2015: Policy reviewed. Policy statement unchanged. Investigative definition updated in policy guidelines section.

06/08/2016: Policy number L.7.01.429 added.

06/30/2023: Policy reviewed; no changes.

06/25/2024: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.82

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

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