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The Role of Rotator Interval Closure in Bankart Lesion Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Dianne Bryant, University of Western Ontario, Canada.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01620619
First Posted: June 15, 2012
Last Update Posted: April 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dianne Bryant, University of Western Ontario, Canada
  Purpose
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

Condition Intervention
Bankart Lesions Anterior Shoulder Instability Other: Arthroscopic Bankart Repair alone Procedure: Closure of rotator interval

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Rotator Interval Closure in Bankart Lesion Repair

Further study details as provided by Dianne Bryant, University of Western Ontario, Canada:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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

  • 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

  • Upper Extremity Functional Index [ Time Frame: 3,6 weeks; 3,6 months; 1,2 years ]
    Limb-specific quality of life measurement tool (20 questions)

  • Recurrence [ Time Frame: 3,6 weeks; 3,6 months; 1,2 years ]
    Patient-reported re-dislocation


Estimated Enrollment: 142
Study Start Date: February 2010
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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?

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 51 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620619


Contacts
Contact: Dianne Bryant, PhD 5196612111 ext 83947 dianne.bryant@uwo.ca

Locations
Canada, Ontario
London Health Sciences Centre - Unviersity Hospital Recruiting
London, Ontario, Canada
Principal Investigator: Robert Litchfield, MD, FRCSC         
Sub-Investigator: Kevin Willits, MD, FRCSC         
Sub-Investigator: Marie Eve LeBel, MD, FRCSC         
Sub-Investigator: Dianne Bryant, PhD         
Sub-Investigator: Tyler Groves, BSc         
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Study Director: Dianne Bryant, PhD University of Western Ontario, Canada
  More Information

Responsible Party: Dianne Bryant, Associate Professor, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01620619     History of Changes
Other Study ID Numbers: FKSMC 2010 - 4
First Submitted: June 4, 2012
First Posted: June 15, 2012
Last Update Posted: April 25, 2014
Last Verified: April 2014

Keywords provided by Dianne Bryant, University of Western Ontario, Canada:
Shoulder
Bankart
Anterior Instability
Rotator Cuff

Additional relevant MeSH terms:
Bankart Lesions
Shoulder Fractures
Fractures, Bone
Wounds and Injuries
Shoulder Injuries