Background

Shoulder instability is a relatively common occurrence, reported in between 2% and 8% of the population. The condition may arise from a single traumatic event (ie, 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, ie, 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 (ie, 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 (ie, 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 syndrome.

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

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

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


Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.

Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE-SNP Coverage:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE:

At the time this policy was created, there were minimal data published in the peer-reviewed literature regarding the use of thermal capsulorrhaphy, and there were a number of unresolved issues regarding the technique.(1,2) This policy has since been updated on a periodic basis using the PUBMED database. The most recent update was performed through April 12, 2016. Following is a summary of the key literature to date.

Thermal Capsulorrhaphy of the Shoulder

The evidence on thermal capsulorrhaphy for the shoulder is derived from 1 small randomized controlled trial (RCT), several nonrandomized comparative studies, and 2 large case series with midterm follow-up. Reports of adverse events are also reviewed.

Randomized Controlled Trials: In 2006, a Canadian workgroup reported a multicenter RCT that had been recruiting subjects since 1999.(3) Enrollment was slower than anticipated; 19 patients treated with thermal capsulorrhaphy and 15 subjects treated with surgical repair had completed 2-year follow-up as of publication. This trial is listed as being completed as of March 2010 with an enrollment of 58 patients (see Table 1); however, no results of this trial are identified in the published literature.

Nonrandomized Comparative Studies: Levitz et al reported a study of 82 baseball players undergoing arthroscopic surgery for internal impingement in 2001.(4) The first 51 patients underwent traditional arthroscopic surgery, consisting of debridement of tears in the rotator cuff and attachment of labral tears. There was no attempt to reduce the capsular laxity. The next 31 patients underwent traditional arthroscopic surgery and also underwent thermal capsulorrhaphy. The main outcome measure was time to return to competition. Among those who did not undergo thermal capsulorrhaphy, 80% returned to competition at a mean time of 7.2 months, with 67% still competing after 30 months. Among those who did undergo thermal capsulorrhaphy, 93% returned to competition at a mean time of 8.4 months, with 90% still competing after 30 months.

Savoie and Field compared the outcomes of patients with multidirectional instability who were treated with either thermal capsulorrhaphy (n=30) or arthroscopic capsular shift (ie, suture repair) (n=26) in 2000.(5) Additional arthroscopic procedures were performed in both groups, as needed. Two patients treated with thermal capsulorrhaphy had an unsatisfactory outcome compared with 3 patients in the suture repair group.

Chen et al reported on 40 patients who underwent combined arthroscopic labral repair and thermal capsulorrhaphy; the results were compared with a historical control group of 32 patients who underwent the same surgery without capsulorrhaphy in 2005.(6) There was no difference in outcomes in the 2 groups, leading the authors to conclude that thermal capsulorrhaphy neither improved nor compromised the results of conventional arthroscopic treatment.

In 2001, Levy et al reported on 90 patients (99 shoulders) with shoulder instability treated with thermal capsulorrhaphy using either radiofrequency (34 patients, 38 shoulders) or laser energy (56 patients, 61 shoulders) and followed up for 23 to 40 months.(7) In the laser-treated group, 59% of the patients considered their shoulder to be "better" or "much better," with a 36.1% failure rate. In the radiofrequency-treated group, 76.9% of patients felt "better" or "much better," with a 23.7% failure rate.

Case Series: D’Alessandro et al published the results of a prospective study of 84 patients who underwent thermal capsulorrhaphy for various indications in 2004.(8) With an average follow-up of 38 months, 37% of patients reported unsatisfactory results, based on reports of pain, instability, return to work, and the American Shoulder and Elbow Surgeons Shoulder Assessment score. The authors reported that the high rate of unsatisfactory results was of great concern. Levine et al reported that the initial wave of enthusiasm for thermal capsulorrhaphy has largely subsided, given the negative results reported by D’Alessandro et al.(9)

Two- to 6-year follow-up was reported on 85 of 100 consecutive patients treated with thermal capsulorrhaphy for glenohumeral instability in 2007.(10) Thirty-seven patients (43.5%) were considered to have had a failed procedure, defined as recurrent instability, revision of surgery, and recalcitrant pain or stiffness requiring manipulation. Deterioration of efficacy over time was reported from a series of 12 overhead athletes (volleyball, tennis, baseball, swimming) who presented with internal impingement at an average age of 27 years (range, 23 to 34).(12) At 2 years after surgery, the modified Rowe score had increased from 45.8 to 90.4; at 7 years postoperatively, the Rowe score had decreased to 70.4 and visual analog scale score for pain was 4.8. Twenty-five percent of athletes reported that they had returned to their preinjury level of competition, 25% played at a lower level, and 50% had stopped because of their shoulder pain.

Other Joints

Literature on thermal capsulorrhaphy for joints other than the shoulder is limited. One small case series (13 patients) from 2007 reported use of thermal capsulorrhaphy for palmar midcarpal instability.(12) A 2008 publication describes thermal capsulorrhaphy for the parapatellar capsule as controversial.(13)

Adverse Events

In 2007, Good et al conducted a retrospective chart review on patients who had been referred for shoulder stiffness and had developed glenohumeral chondrolysis.(14) Of the 8 patients who had developed glenohumeral chondrolysis after shoulder arthroscopy, 5 had undergone thermal capsulorrhaphy for shoulder instability, and 3 had a thermal procedure with labral repair or synovectomy. The onset was described as early and rapid, with repeat arthroscopy to confirm the diagnosis of chondrolysis and rule out infection at an average of 8 months after the initial shoulder arthroscopy. The mean age of the patients was 23 years (range, 15-39 years). None of the patients had evidence of chondral damage at the index arthroscopy, and none had received postoperative intra-articular pain pumps, a procedure which has also been associated with chondrolysis. The patients required between 1 and 6 procedures after the onset of chondrolysis to manage their pain, including glenoid allograft, humeral head arthroplasty, and total shoulder arthroplasty. Good et al identified an additional 10 reported cases of glenohumeral chondrolysis following shoulder arthroscopy in the English-language literature. Five of the 10 cases occurred after the use of gentian violet dye injection into the joint to identify a rotator cuff tear; this technique has since been abandoned. Of the remaining 5 reported cases, 4 involved the use of a thermal device during the procedure. An accompanying editorial by the journal’s editors concluded that “pending evidence to the contrary, shoulder thermal capsulorrhaphy is a procedure in which these and other reported risks outweigh any potential benefits.”(15)

A 2010 review of shoulder instability in patients with joint hyperlaxity indicates that although initial results with thermal capsulorrhaphy seemed promising, subsequent studies with longer follow-up showed “unacceptably high rates of failure and postoperative complications”, including cases of postoperative axillary nerve palsy and transient deltoid weakness.(16) Abnormal capsular tissue has also been observed in the areas of previous thermal treatment, with either severe thickening or thin, friable deficient capsule. In a 2011 review, Virk and Kocher describe thermal capsulorrhaphy as a failed new technology in sports medicine.(17)

Ongoing and Unpublished Clinical Trials - None Found

Table 1. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT00251160a	Electrothermal Arthroscopic Capsulorrhaphy (ETAC) and Open Inferior Capsular Shift in Patients With Shoulder Instability	58	Feb 2010

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial

Results have been published in Mohtadi NG, Kirkley A, Hollinshead RM, McCormack R, MacDonald PB, Chan DS, Sasyniuk TM, Fick GH, Paolucci EO; Joint Orthopaedic Initiative for National Trials of the Shoulder-Canada. Electrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial. J Shoulder Elbow Surg. 2014 Aug;23(8):1171-80. doi: 10.1016/j.jse.2014.02.022. Epub 2014 Jun 15.

Summary of Evidence

The literature does not support use of thermal capsulorrhaphy. The few available comparative studies do not support that this procedure is an efficacious treatment for shoulder instability. The case series report a high rate of unsatisfactory results and complications, raising the potential for a net harm. Because of the lack of efficacy and potential for harm, this procedure is considered not medically necessary.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements
In 2010, the American Academy of Orthopaedic Surgeons published patient information on thermal capsular shrinkage.(18) The information provided stated that thermal capsular shrinkage was developed as a less invasive way to treat a shoulder that is loose and frequently dislocates. Early short-term results were promising and the procedure gained in popularity. However, more recent results over a longer follow-up period have shown a much higher failure rate and more complications than were first reported. As a result, the procedure is used less frequently.

U.S. Preventive Services Task Force Recommendations
Not applicable.]

Up To Date
A meta-analysis of studies of surgical management for multidirectional instability reported significantly higher recurrence rates for patients treated with thermal capsular shrinkage, suggesting that such treatment is best avoided.

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Thermal Capsulorrhaphy as a Treatment of Joint Instability
Thermal Capsular Shrinkage
Arthroscopic Thermal Capsular Shrinkage
Arthroscopic Thermal Reduction of Capsular Volume
Capsular Shrinkage
Capsulorrhaphy, Thermal
Electrothermal Capsular Shrinkage
LACS (Laser-Assisted Capsular Shift)
Laser-Assisted Capsular Shift (LACS)
Laser Thermal Capsulorrhaphy
Shoulder Instability, Capsular Shrinkage for
Thermal Capsulorrhaphy

References:
1. Abrams JS. Thermal capsulorrhaphy for instability of the shoulder: concerns and applications of the heat probe. Instr Course Lect 2001; 50:29-36.

2. Gryler EC, Greis PE, Burks RT et al. Axillary nerve temperatures during radiofrequency capsulorrhaphy of the shoulder. Arthroscopy 2001; 17(6):567-72.

3. Mohtadi NG, Hollinshead RM, Ceponis PJ et al. A multi-centre randomized controlled trial comparing electrothermal arthroscopic capsulorrhaphy versus open inferior capsular shift for patients with shoulder instability: protocol implementation and interim performance: lessons learned from conducting a multi-centre RCT [ISRCTN68224911; NCT00251160]. Trials 2006; 7:4.

4. Levitz CL, Dugas J, Andrews JR. The use of arthroscopic thermal capsulorrhaphy to treat internal impingement in baseball players. Arthroscopy 2001; 17(6):573-7.

5. Savoie FH, 3rd, Field LD. Thermal versus suture treatment of symptomatic capsular laxity. Clin Sports Med 2000; 19(1):63-75, vi.

6. Chen S, Haen PS, Walton J et al. The effects of thermal capsular shrinkage on the outcomes of arthroscopic stabilization for primary anterior shoulder instability. Am J Sports Med 2005; 33(5):705-11.

7. Levy O, Wilson M, Williams H et al. Thermal capsular shrinkage for shoulder instability. Mid-term longitudinal outcome study. J Bone Joint Surg Br 2001; 83(5):640-5.

8. D'Alessandro DF, Bradley JP, Fleischli JE et al. Prospective evaluation of thermal capsulorrhaphy for shoulder instability: indications and results, two- to five-year follow-up. Am J Sports Med 2004; 32(1):21-33.
9. Levine WN, Bigliani LU, Ahmad CS. Thermal capsulorrhaphy. Orthopedics 2004; 27(8):823-6.

10. Hawkins RJ, Krishnan SG, Karas SG et al. Electrothermal arthroscopic shoulder capsulorrhaphy: a minimum 2-year follow-up. Am J Sports Med 2007; 35(9):1484-8.

11. Jansen N, Van Riet RP, Meermans G et al. Thermal capsulorrhaphy in internal shoulder impingement: a 7-year follow-up study. Acta Orthop Belg 2012; 78(3):304-8.

12. Mason WT, Hargreaves DG. Arthroscopic thermal capsulorrhaphy for palmar midcarpal instability. J Hand Surg Eur Vol 2007; 32(4):411-6.

13. Zheng N, Davis BR, Andrews JR. The effects of thermal capsulorrhaphy of medial parapatellar capsule on patellar lateral displacement. J Orthop Surg Res 2008; 3:45.

14. Good CR, Shindle MK, Kelly BT et al. Glenohumeral chondrolysis after shoulder arthroscopy with thermal capsulorrhaphy. Arthroscopy 2007; 23(7):797 e1-5.

15. Lubowitz JH, Poehling GG. Glenohumeral thermal capsulorrhaphy is not recommended--shoulder chondrolysis requires additional research. Arthroscopy 2007; 23(7):687.

16. Johnson SM, Robinson CM. Shoulder instability in patients with joint hyperlaxity. J Bone Joint Surg Am 2010; 92(6):1545-57.

17. Virk SS, Kocher MS. Adoption of new technology in sports medicine: case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy. Arthroscopy 2011; 27(1):113-21.

18. American Academy of Orthopaedic Surgeons (AAOS). OrthoInfo: Thermal Capsular Shrinkage. 2010; http://orthoinfo.aaos.org/topic.cfm?topic=a00034. Accessed April, 2015.

19. Rolfes K. Arthroscopic treatment of shoulder instability: a systematic review of capsular plication versus thermal capsulorrhaphy. J Athl Train 2015 Jan; 50(1):105-9.

20. Longo UG, Rizzello G, Loppini M, et al. Multidirectional Instability of the Shoulder: A Systematic Review. Arthroscopy 2015 Dec; 31(12):2431-43.

21. Chen D, Goldberg J, Herald J, et al. Effects of surgical management on multidirectional instability of the shoulder: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2016 Feb; 24(2):630-9.

22. Berkoff DJ. Multidirectional instability of the shoulder. In Up to Date (2018) Grayzel J. (Ed). UpToDate, Waltham, MA. (Accessed February 23, 2018).

23. Mohtadi NG, Kirkley A, Hollinshead RM, McCormack R, MacDonald PB, Chan DS, Sasyniuk TM, Fick GH, Paolucci EO; Joint Orthopaedic Initiative for National Trials of the Shoulder-Canada. Electrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial. J Shoulder Elbow Surg. 2014 Aug;23(8):1171-80. doi: 10.1016/j.jse.2014.02.022. Epub 2014 Jun 15.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

29999

S2300