An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS
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|ClinicalTrials.gov Identifier: NCT00182299|
Recruitment Status : Unknown
Verified April 2007 by McMaster University.
Recruitment status was: Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : April 20, 2007
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Procedure: porcine small intestine submucosa (SIS)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||September 2003|
|Estimated Study Completion Date :||April 2008|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182299
|The University of Western Ontario|
|London, Ontario, Canada, N6G 1H1|
|Principal Investigator:||Dianne M Bryant, PhD||University of Western Ontario, Canada|