Prospective Randomized Comparative Study of Outcome of Subscapularis Tear

NCT01996904 | Completed Results DMC

• 1 other identifier: CMH-2013-03
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Syndrome

Keywords

subscapularis tear; arthroscopic tendon repair; arthroscopic tendon debridement; ASES

Outcome Measures

Primary Outcomes (1)

• ASES Score

  The ASES is a 100-point scale which is divided in two sections. Fifty points of which are derived from patient self-report of pain and the other 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living .The item related to pain is evaluated by a VAS (10 cm) that ranges from 0 (no pain at all) to 10 (pain as bad as it can be). The ten activities of daily living include skills such as putting on a coat, sleeping on the affected side, wash back/do up bra in back, manage toileting, combing one's hair, reach a high shelf, lift 10lbs above shoulder,throw a ball overhand,do usual work and do usual sport.The items related to function are evaluated by a four-point Likert scale. The scores of the pain and function subsections are transformed in percentages and each one represents 50% of the final score, which can range from 0 (absence of function) to 100 (normal function).

  24th month

Secondary Outcomes (1)

• Ultrasound Diagnosis

  every three months after the surgery until the 24th month

Study Arms (2)

arthroscopic repair

EXPERIMENTAL

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.

Procedure: arthroscopic repair

arthroscopic debridement

ACTIVE COMPARATOR

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.

Procedure: arthroscopic debridement

Interventions

arthroscopic repair 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 repair

arthroscopic debridement 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.

arthroscopic debridement

Eligibility Criteria

• Age: 44 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CM Chungmu Hospital: lead

Study Sites (1)

CM Chungmu Hospital

Seoul, Yeongdeungpo-gu, 150-034, South Korea

Location

Limitations and Caveats

Limitation of this study was the low retention of patients during follow-up period. Our cases only yielded 75% retention of patients after twenty-four-months follow-up and this might act as a bias in our study.

Results Point of Contact

• Title: Sang-Hoon Lhee
• Organization: CM Chungmu Hospital

cmirb@naver.com

+82(2)2068/4525

Study Officials

• Sang-Hoon Lhee, MD, PhD

  CM Chungmu Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of CM Chungmu Hospital

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: March 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 12, 2014
• Results First Posted: March 12, 2014

Record last verified: 2014-01

Locations

KR (1)