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

Primary Purpose

Rotator Cuff Tear

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
porcine small intestine submucosa (SIS)
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Western Ontario

Outcomes

Primary Outcome Measures

MRI defined failure of the cuff repair at 2 years postoperative

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
April 19, 2007
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Canadian Institutes of Health Research (CIHR), DePuy Orthopaedics, London Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00182299
Brief Title
An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Canadian Institutes of Health Research (CIHR), DePuy Orthopaedics, London Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
porcine small intestine submucosa (SIS)
Primary Outcome Measure Information:
Title
MRI defined failure of the cuff repair at 2 years postoperative
Secondary Outcome Measure Information:
Title
Quality of life (WORC, ASES), function (SST, CONSTANT), general health (SF-36), pain (VAS), analgesic use; forward flexion; internal/external rotation; lateral elevation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianne M Bryant, PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 1H1
Country
Canada

12. IPD Sharing Statement

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

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