Rotator cuff tears Musculoskeletal Diseases Large rotator cuff tears
Conditions
Interventions
1. Standard open rotator cuff repair
2. Standard open rotator cuff repair augmented with porcine small intestine submucosa (RESTORE patch)
Sponsors
McMaster University (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. The Western Ontario Rotator Cuff Index (WORC) 2. The American Shoulder and Elbow Surgeons standardized tool (ASES) 3. The Simple Shoulder Test (SST) 4. The Constant 5. The SF-36 | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada
Outcome results
None listed