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

NCT00182299 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2007-04-20

No results posted yet for this study

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

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

porcine small intestine submucosa (SIS)

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • London Health Sciences Centre

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Dianne M Bryant, PhD · Western University, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Completion
2008-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00182299 on ClinicalTrials.gov