A randomized clinical trial comparing the effectiveness of rotator cuff repair with or without augmentation with porcine small intestine submucosa (SIS) for large rotator cuff tears: Pilot study phase

Not Applicable

Completed

• Conditions: Rotator cuff tears; Musculoskeletal Diseases; Large rotator cuff tears

• Registration Number: ISRCTN73698035
• Lead Sponsor: McMaster University (Canada)

Brief Summary

2016 results in https://pubmed.ncbi.nlm.nih.gov/27545050/ (added 12/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-05
• Study Completion: 2007-04-30
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Patients (18 - 65 years old, either sex) with large rotator cuff tears (Type 1B or Type 2) determined by clinical examination and diagnostic imaging. Criteria described by Harryman et al. (1991) will guide the classification of rotator cuff tears defined and reassessed at the time of surgery (Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B = full thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 = full thickness defect of three tendons).

Exclusion Criteria

1. Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy
2. Inability of the surgeon to repair the tear with remaining defect no greater than 5 mm in diameter
3. Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion, Bankart lesion
4. Active joint or systemic infection
5. Significant muscle paralysis of the shoulder girdle
6. Migration of the humeral head as demonstrated on plain radiograph
7. Major medical illness that would preclude undergoing surgery
8. Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
9. Major psychiatric illness, developmental handicap or inability to read and understand the English language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success or failure of the rotator cuff repair. Patients will undergo Magnetic Resonance Imaging (MRI) of the rotator cuff one year post-operatively to determine whether the defect has healed, and if not healed completely, whether the remaining full thickness defect is greater than 5 mm in any dimension. If such a defect remains, the patient is classified as having failed the repair.

Secondary Outcome Measures

Name	Time	Method
<br> 1. The Western Ontario Rotator Cuff Index (WORC)<br> 2. The American Shoulder and Elbow Surgeons standardized tool (ASES)<br> 3. The Simple Shoulder Test (SST)<br> 4. The Constant<br> 5. The SF-36<br>