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

April 19, 2007 updated by: Hamilton Health Sciences Corporation

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6G 1H1
        • The University of Western Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with large rotator cuff tears (Type 1B or Type 2) determined by clinical examination and diagnostic imaging. Criteria described by Harryman et al (1991) will guide the classification of rotator cuff tears defined and reassessed at the time of surgery (Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B= full thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 = full thickness defect of three tendons).

Exclusion Criteria:

  • Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy.
  • Inability of the surgeon to repair the tear with remaining defect no greater than 10mm in diameter,
  • Inability of the surgeon to repair the tear with less than 1cm of medialization,
  • Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis).
  • Active joint or systemic infection,
  • Significant muscle paralysis of the shoulder girdle,
  • Major medical illness that would preclude undergoing surgery,
  • Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
  • Major psychiatric illness, developmental handicap or inability to read and understand the English language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
MRI defined failure of the cuff repair at 2 years postoperative

Secondary Outcome Measures

Outcome Measure
Quality of life (WORC, ASES), function (SST, CONSTANT), general health (SF-36), pain (VAS), analgesic use; forward flexion; internal/external rotation; lateral elevation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)
DePuy Orthopaedics
London Health Sciences Centre

Investigators

  • Principal Investigator: Dianne M Bryant, PhD, Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Anticipated)

April 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

April 20, 2007

Last Update Submitted That Met QC Criteria

April 19, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63140-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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