Surgery Section - Thermal Capsulorrhaphy as a Treatment of Joint Instability

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

Description

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 (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., 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 modification or surgery may be considered. Activity modifications may be appropriate for those 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 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 SLAP [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 Corporation, Sunnyvale, CA).

Thermal Capsulorrhaphy of the Knee and and other Joints

Thermal capsulorrhaphy has been proposed as a treatment of anterior cruciate ligament rupture and for cutting and contouring soft tissue of other joints such as the wrist, ankle, and elbow.

Policy/Criteria

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

Scientific Background

There are minimal data published in the peer-reviewed literature regarding the use of thermal capsulorrhaphy, either as a sole arthroscopic procedure, or as an adjunct to other arthroscopic repair of shoulder lesions. Unresolved issues regarding the technique include the following (2,3):

• Identifying and quantifying joint laxity
• Optimal temperature and length of exposure to heat
• Variable response of collagen to heat, based on patient age and other factors
• Control of tissue shrinkage (both at the time of surgery and during follow-up as the acute thermal damage heals)
• Effect of potential temperature damage on proprioceptive and position-sensitive nerve endings within the capsule
• Risk of capsular ablation
• Risk of neurologic complications
• Appropriate rehabilitation (i.e., length of immobilization during the healing phase, followed by exercise)

Thermal Capsulorrhaphy as the Sole Arthroscopic Procedure

Levy and colleagues reported on a case series of 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 for 23 to 40 months. (4) Selection criteria included all of the following: 1) a history of either repetitive microtrauma or a minimal traumatic event leading to recurrent symptoms; 2) clinical examination revealing generalized laxity; and 3) arthroscopic finding of a voluminous capsule with increased joint volume. Following diagnostic arthroscopy, thermal capsulorrhaphy was the only arthroscopic treatment performed. Outcomes included assessment of pain, stability, mobility, and return to sport or daily activities. In the laser-treated group, 59% of the patients considered their shoulder to be "better" or "much better", while there was a failure rate of 36.1%. In the radiofrequency-treated group, 76.9% of patients felt "better" or "much better", with a 23.7% failure rate. The authors report that these results match those of some reported case series of open repair of multidirectional instability, and suggest that due to the minimal morbidity of the arthroscopic approach, thermal shrinkage is a viable alternative to open surgery.

Thermal Capsulorrhaphy Combined with Other Arthroscopic Procedures

Levitz and colleagues reported on a case series of 82 baseball players undergoing arthroscopic surgery for internal impingement. (5) 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 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.

Mishra and colleagues reported on the 2-year outcomes of 41 athletes with recurrent traumatic anterior dislocations and capsulolabral avulsions who were treated with arthroscopic Bankart repair in conjunction with thermal capsulorrhaphy. (6) At a mean of 28 months postoperatively, 38 athletes had returned to their preinjury sport; three suffered traumatic redislocations, for a 7% failure rate. The authors conclude that these results are similar to those associated with open surgical repair.

Savoie and Field compared the outcomes of two different series of patients with multidirectional instability who were treated with either thermal capsulorrhaphy (n=30) or arthroscopic capsular shift (i.e., suture repair) (n=26). (7) Additional arthroscopic procedures were performed in both groups, as needed. Two patients treated with thermal capsulorrhaphy had an unsatisfactory outcome compared to three patients in the suture repair group. The authors concluded that thermal capsulorrhaphy is an effective treatment alternative for patients with multidirectional instability.

The published peer-reviewed literature regarding the use of thermal capsulorrhaphy of the shoulder consists of uncontrolled case series of patients. The policy was updated in April 2004 with an additional search of the literature based on MEDLINE. Additional published articles include review articles (8-10) and case series of thermal capsulorrhaphy of the shoulder. (11, 12)

D’Alessandro and colleagues published the results of a prospective study of 84 patients who underwent thermal capsulorrhaphy for various indications. (13) 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 report that the high rate of unsatisfactory results is of great concern.  Levine and colleagues reported that the initial wave of enthusiasm for thermal capsulorrhaphy has largely subsided, given the negative results reported by D‘Allesandro. (14)

Chen and colleagues reported on a case series of 40 patients who underwent combine 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. (15) There was no difference in outcomes in the two groups, leading the authors to conclude that capsulorrhaphy neither improved nor compromised the results of conventional arthroscopic treatment.

Two to six year follow-up was reported on 85 of 100 consecutive patients treated with thermal capsulorrhaphy for glenohumeral instability. (16) 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. The authors concluded that this compares unfavorably with the reported 7.5% failure rate when thermal capsulorrhaphy is used to supplement suture plication, and they now generally use it only in combination with other surgical procedures. No studies were identified that assessed whether thermal capsulorrhaphy improves outcomes when combined with other arthroscopic procedures.

Additionally, the literature was specifically searched for articles focusing on thermal capsulorrhaphy of joints other than the shoulder. Mason and Hargreaves reported early results of arthroscopic thermal capsulorrhaphy for palmar midcarpal instability in 15 wrists in 13 patients. (17) At mean followup of 42 months, all wrists showed improvement or resolution of instability and improvement in function. No other studies were found in the MEDLINE database that focused on capsulorrhaphy of joints other than the shoulder.

An updated literature search through October 10, 2008 did not return any new clinical trial data on thermal capsulorrhaphy for any joint.  Based on the lack of evidence from well-designed, randomized clinical trials comparing shoulder thermal capsulorrhaphy to standard surgical repair of shoulder joint instability, the five technology evaluation criteria are not met  The evidence from uncontrolled case series that has evolved over the past several years has indicated unsatisfactory outcomes with thermal capsulorrhaphy.  Therefore the policy for thermal capsulorrhaphy for shoulder instability is now considered investigational.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.82
2. Abrams JS. Thermal capsulorrhaphy for instability of the shoulder: concerns and applications of the heat probe. Instr Course Lect 2001; 50: 29-36
3. Gryler EC, Greis PE, Burks RT et al. Axillary nerve temperatures during radiofrequency capsulorrhaphy of the shoulder. Arthroscopy 2001;17(6):567-72
4. 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
5. Levitz CL, Dugas J, Andrews JR. The use of arthroscopic thermal capsulorrhaphy to treat internal impingement in baseball players. J Arthroscopic and Rel Surg July-August 2001;17:573-577
6. Mishra DK, Fanton GS. Two-year outcome of arthroscopic Bankart repair and electrothermal-assisted capsulorrhaphy for recurrent traumatic anterior shoulder instability. J Arthroscopy and Rel Surg Oct 2001;17:844-849
7. Savoie FH III, Field LD. Thermal versus suture treatment of symptomatic capsular laxity. Clin Sports Med 2000; 19(1): 63-75
8. Wolf RS, Lemak LJ. Thermal capsulorrhaphy in the treatment of multidirectional instability of the shoulder. J South Orthop Assoc 2002;11(2):102-9
9. Sekiya JK, Ong BC, Bradley JP. Thermal capsulorrhaphy to treat should instability. Instr Course Lect 2003;52:65-80
10. Gerber A, Warner JJ. Thermal capsulorrhaphy to treat shoulder instability. Clin Orthop 2002;400:105-16
11. Gieringer RE. Arthroscopic monopolar radiofrequency thermal capsulorrhaphy for the treatment of shoulder instability: a prospective outcome study with mean 2-year follow-up. Alaska Med 2003;45(1):3-8
12. Hovis WD, Dean MT, Mallon WJ et al. Posterior instability of the shoulder with secondary impingement in elite golfers. Am J Sports Med 2002;30(6):886-90
13. D’Alessandro DF, Bradley JP, Fleischi JE et al. Prospective evaluation of thermal capsulorrhaphy for should instability: Indications and results, two- and five-year follow up. Am J Sports Med 2004;32:21-33
14. Levine WN, Bigliani LU, Ahmad CS. Thermal capsulorrhaphy. Orthopedics 2004;27:823-26
15. Chen S, Haen PS, Walton J et al. The effects of thermal capsular shrinkage on the outcomes of arthroscopic stabilization for primary anterior should instability. Am J Sports Med 2005;33(5):705-11
16. 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
17. Mason WT, Hargreaves DG. Arthroscopic thermal capsulorrhaphy for palmar midcarpal instability. J Hand Surg Eur Vol. 2007;32(4):411-6

Cross References

Percutaneous Intradiscal Electrothermal Annuloplasty (IDET) and Percutaneous Intradiscal Radiofrequency Thermocoagulation, Regence Medical Policy Manual, Surgery, Policy No. 118

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