The Role of Rotator Interval Closure in Bankart Lesion Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Western Ontario, Canada
Sponsor:
Information provided by (Responsible Party):
Dianne Bryant, University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01620619
First received: June 4, 2012
Last updated: April 24, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Rotator Interval Closure in Bankart Lesion Repair

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

Primary Outcome Measures:
  • Western Ontario Shoulder Instability Index [ Time Frame: 3,6 weeks;3,6 months; 1,2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Limb-specific quality of life measurement tool (20 questions)

  • Recurrence [ Time Frame: 3,6 weeks; 3,6 months; 1,2 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   15 Years to 51 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 4, 2012
Last Updated: April 24, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 15, 2014