An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS
Recruitment status was Active, not recruiting
The prognosis for patients with large rotator cuff tears is poor. This recently developed biologic scaffold provides numerous structural and functional properties that may direct cell growth and aid in tendon healing. To date, there are no randomized clinical trials assessing the effectiveness of the patch to augment repairs of large rotator cuff tears. We propose a study to compare the rate of repair failure, quality of life, function, pain, and range of motion in 60 patients with large rotator cuff. Patients will be randomized (like flipping a coin) to undergo a standard rotator cuff repair with or without augmentation with SIS. Patients are assessed at 6 weeks, 3, 6, 12, 18, and 24 months post-operative
Rotator Cuff Tear
Procedure: porcine small intestine submucosa (SIS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- MRI defined failure of the cuff repair at 2 years postoperative
- Quality of life (WORC, ASES), function (SST, CONSTANT), general health (SF-36), pain (VAS), analgesic use; forward flexion; internal/external rotation; lateral elevation
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||April 2008|
Objective of the full randomized trial To compare the effectiveness of a standardized method of rotator cuff repair with or without augmentation using porcine small intestine submucosa (SIS) in patients with large rotator cuff tears.
Objectives of the pilot study
- To obtain a preliminary estimate of the likely success of SIS.
- To formally evaluate our ability to successfully recruit eligible patients into this study.
- To determine appropriate length of follow up through examination of the pattern of incremental improvement and stabilization of quality of life over time following rotator cuff repair.
- To determine a more accurate estimation of sample size for the full trial using quality of life.
- To determine the frequency with which surgeons comply with the surgical protocol.
- To determine the frequency with which patients and physiotherapists comply with the suggested physiotherapy protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182299
|The University of Western Ontario|
|London, Ontario, Canada, N6G 1H1|
|Principal Investigator:||Dianne M Bryant, PhD||University of Western Ontario, Canada|