The Role of Rotator Interval Closure in Bankart Lesion Repair

April 24, 2014 updated by: Dianne Bryant, University of Western Ontario, Canada
The null hypothesis is that there is no statistical difference between the two treatment groups for any outcome. The investigators suspect that patients who undergo a Bankart lesion repair with rotator interval closure will have lower quality of life and less external rotation compared to patients who undergo a Bankart lesion repair alone. No difference will be observed for recurrence rate between the two treatment groups

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Research assessing the role and effectiveness of rotator interval closure is important to attempt to determine the most beneficial and efficient treatment for Bankart lesions and anterior shoulder instability. To date there is only weak evidence supporting the superiority of Bankart lesion repair in addition to rotator interval closure compared to Bankart lesion repair alone.

Does Bankart lesion repair with rotator interval closure result in differences in quality of life, range of motion and recurrence at 3 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years in similar patients with Bankart lesions who are treated with Bankart lesion repair alone?

Study Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

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
        • Recruiting
        • London Health Sciences Centre - Unviersity Hospital
        • Principal Investigator:
          • Robert Litchfield, MD, FRCSC
        • Sub-Investigator:
          • Marie Eve LeBel, MD, FRCSC
        • Sub-Investigator:
          • Tyler Groves, BSc

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

15 years to 51 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between the ages of 15 to 50 years
  • At least one episode of demonstrated dislocation
  • Bankart lesion of the anterior glenoid labrum
  • Absence of other capsular and tendon injuries
  • Absence of glenoid fractures or divots

Exclusion Criteria:

  • Posterior instability or the need for posterior surgical reconstruction
  • Significant bone lesions greater than 3mm of the humeral head anterior-to- posterior (Hill-Sachs lesions)
  • Presence of other pathologic conditions of the shoulder (excluding SLAP lesions)

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arthroscopic Bankart Repair & Rotator Interval Closure
Procedure: Closure of rotator interval
Usual arthroscopic Bankart repair plus rotator cuff interval closure
ACTIVE_COMPARATOR: Arthoscopic Bankart Repair alone
Other: Arthroscopic Bankart Repair alone
Usual arthroscopic Bankart repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario Shoulder Instability Index
Time Frame: 3,6 weeks;3,6 months; 1,2 years
Disease-specific quality of life measurement tool (21 questions, 4 domains)
3,6 weeks;3,6 months; 1,2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: 3,6 months; 1-2 years
  • Universal goniometer
  • Internal & external ROM at neutral (0°) and 90° of abduction
  • Both active and passive ROM at both positions
3,6 months; 1-2 years
4-Item Pain Intensity Measure
Time Frame: 3,6, weeks; 3, 6 months; 1,2 years
Pain intensity in the morning, afternoon, evening and with activity
3,6, weeks; 3, 6 months; 1,2 years
Upper Extremity Functional Index
Time Frame: 3,6 weeks; 3,6 months; 1,2 years
Limb-specific quality of life measurement tool (20 questions)
3,6 weeks; 3,6 months; 1,2 years
Recurrence
Time Frame: 3,6 weeks; 3,6 months; 1,2 years
Patient-reported re-dislocation
3,6 weeks; 3,6 months; 1,2 years

Collaborators and Investigators

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

Sponsor

University of Western Ontario, 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

February 1, 2010

Primary Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (ESTIMATE)

June 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKSMC 2010 - 4

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.

Subscribe