NCT00182299

An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 1. To obtain a preliminary estimate of the likely success of SIS. 2. To formally evaluate our ability to successfully recruit eligible patients into this study. 3. 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. 4. To determine a more accurate estimation of sample size for the full trial using quality of life. 5. To determine the frequency with which surgeons comply with the surgical protocol. 6. To determine the frequency with which patients and physiotherapists comply with the suggested physiotherapy protocol.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
PROCEDURE	porcine small intestine submucosa (SIS)

Timeline

• Start date: 2003-09-01
• Completion: 2008-04-01
• First posted: 2005-09-16
• Last updated: 2007-04-20

Locations

1 site across 1 country: Canada