Prospective Randomized Comparative Study of Outcome of Subscapularis Tear

NCT ID: NCT01996904

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-10-31

Brief Summary

The purpose of this study was to report actual percentage of subscapularis tear in concomitant with supraspinatus tendon tear (with or without infraspinatus tear) and investigate the amount of contribution of subscapularis repair as to the outcome of whole rotator cuff repair in terms of its clinical and radiologic aspects.

Detailed Description

Prospective randomized controlled study was designed to evaluate subscapularis repair in anterosuperior rotator cuff tear compared with debridement of the subscapularis tear. After identification of the subscapularis tear arthroscopically, final eligibility of participants for the study was established on the basis of intra-operative arthroscopic inspection of the subscapularis using 70 degrees arthroscope. Once eligibility was confirmed, patients were randomized to one of two arthroscopic methods; repair (group A) or debridement (group B) of the subscapularis tear. The treatment allocations were decided through an interphone by "Research Coordinator". Block randomization was performed and no stratification was performed. Random Sequence Generator (Random.org) was used for the randomization process by given number whose digit was residue of modulo 2 (0 - group A, 1 - group B). Sequence Boundaries was 1 (smallest value) to 300 (largest value) based on the number calculated from power analysis. After randomization, patients underwent arthroscopic repair or debridement of the subscapularis tear. Size of the rotator cuff tear was also determined by the arthroscopic finding (small-to-medium, medium-to-large, large-to-massive). When full-thickness tear was confined to supraspinatus, the tear was called small-to-medium size tear. Medium-to-Large size tear was defined as complete full-thickness supraspinatus tear combined with incomplete full-thickness infraspinatus tear. Large-to-massive tear consisted of complete full-thickness tear of supraspinatus and infraspinatus or complete full-thickness tear of supraspinatus and subscapularis or complete 3-tendon tears. Postoperatively, rehabilitation was identical for both groups and consisted of sling immobilization for six weeks. Pulley exercises were performed during this time period. After six weeks from the surgery, active-assisted exercise including stick exercise to achieve full range of motion was performed. After 9 weeks from the surgery, Theraband exercise was initiated to strengthen repaired rotator cuff muscles. All patients underwent ultrasound at 24 months follow-up to evaluate integrity of supraspinatus tendon. The evaluation of integrity of supraspinatus tendon was performed and compared between two groups to evaluate the contribution of the subscapularis tendon to rotator cuff integrity. Re-tear of the supraspinatus was carefully evaluated through ultrasound by musculoskeletal radiologists who were experienced in ultrasound-diagnosis of shoulder more than 10 years.

Conditions

Rotator Cuff Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

arthroscopic repair

Lateral-anterosuperior portal ("Miracle Portal") was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.

Group Type: EXPERIMENTAL

arthroscopic repair

Intervention Type: PROCEDURE

If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures.

arthroscopic debridement

Open and arthroscopic cuff debridement procedures have been described in the literatures for management of massive rotator cuff tears; these generally result in decreased pain and overall improvement in patient's function.

Group Type: ACTIVE_COMPARATOR

arthroscopic debridement

Intervention Type: PROCEDURE

Anterosuperior portal was made initially for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was performed.The superior aspect of the tendon was freed from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.

Interventions

arthroscopic repair

If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures.

Intervention Type: PROCEDURE

arthroscopic debridement

Anterosuperior portal was made initially for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was performed.The superior aspect of the tendon was freed from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Full-thickness supraspinatus tear confirmed by preoperative MRI
• Willingness to be enrolled into the study and understanding the whole design of the study
• Patients who is undergoing arthroscopic surgery for rotator cuff repair

Exclusion Criteria

• An irreparable massive rotator cuff tear which shows Stage-3 or 4 fatty infiltration inside the muscle of supraspinatus and subscapularis by MRI
• Cuff tear arthropathy
• Osteoarthritis with joint space narrowing or any joint spur identified in simple radiographs
• A Workers' compensation claim
• Major trauma or rotator cuff tear after shoulder dislocation
• Previous surgery or fracture on ipsilateral extremity
• Intact subscapularis tendon identified during arthroscopic surgery with 70 degrees arthroscope

• Minimum Eligible Age: 44 Years
• Maximum Eligible Age: 83 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CM Chungmu Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang-Hoon Lhee

Director of CM Chungmu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang-Hoon Lhee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CM Chungmu Hospital

Locations

CM Chungmu Hospital

Seoul, Yeongdeungpo-gu, South Korea

Countries

South Korea

Other Identifiers

CMH-2013-03

Identifier Type: -

Identifier Source: org_study_id