Clinical Trial: Pilot Study to Evaluate the Restore Orthobiologic Implant in Rotator Cuff Tear Repair
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Randomised Pilot Study to Determine the Variability of Early Clinical Outcome in Subjects Undergoing Full Thickness Rotator Cuff Tear Repair, When Augmented With or Without Porcine Smal
Brief Summary:
Primary Endpoints:
Comparative evaluation of any differences between the two groups in change from baseline to the 3-month time point in terms of:
- Functional recovery (patient-based) - using the Oxford Shoulder Score.
- Functional recovery and early return of strength (pain, activities of daily living [ADL], range of motion [ROM], and power) - evaluated using the Constant Shoulder Assessment.
- Functional recovery (pain and function - patient-based), evaluated using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment - patient self-report section.
- Region-specific Quality of Life - using the Western Ontario Rotator Cuff (WORC) Index.
- Range of motion - assessed by goniometer recorded as part of the Constant Score.
- Pain (taken from Pain visual analog scale [VAS] of the ASES Shoulder Assessment); and
- Record of escape pain medication usage (recorded in a daily patient diary).
Secondary Endpoints:
Comparative evaluation of any difference between the two groups in change from baseline to the 6-week time point, in terms of:
- Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain medication usage (recorded in a daily patient diary).
Comparative evaluation of any differences between the two groups in change from baseline to the 6-month time point, in terms of:
