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

McMaster University (Canada)0 sites62 target enrollmentSeptember 5, 2005

Overview

Registry

who.int

Start Date

September 5, 2005

End Date

April 30, 2007

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

McMaster University (Canada)

•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).

•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