The Role of Rotator Interval Closure in Bankart Lesion Repair
Primary Purpose
Bankart Lesions, Anterior Shoulder Instability
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Arthroscopic Bankart Repair alone
Closure of rotator interval
Sponsored by
About this trial
This is an interventional treatment trial for Bankart Lesions focused on measuring Shoulder, Bankart, Anterior Instability, Rotator Cuff
Eligibility 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)
Sites / Locations
- London Health Sciences Centre - Unviersity HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arthroscopic Bankart Repair & Rotator Interval Closure
Arthoscopic Bankart Repair alone
Arm Description
Outcomes
Primary Outcome Measures
Western Ontario Shoulder Instability Index
Disease-specific quality of life measurement tool (21 questions, 4 domains)
Secondary Outcome Measures
Range of Motion
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
Pain intensity in the morning, afternoon, evening and with activity
Upper Extremity Functional Index
Limb-specific quality of life measurement tool (20 questions)
Recurrence
Patient-reported re-dislocation
Full Information
NCT ID
NCT01620619
First Posted
June 4, 2012
Last Updated
April 24, 2014
Sponsor
University of Western Ontario, Canada
1. Study Identification
Unique Protocol Identification Number
NCT01620619
Brief Title
The Role of Rotator Interval Closure in Bankart Lesion Repair
Official Title
The Role of Rotator Interval Closure in Bankart Lesion Repair
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Ontario, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bankart Lesions, Anterior Shoulder Instability
Keywords
Shoulder, Bankart, Anterior Instability, Rotator Cuff
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic Bankart Repair & Rotator Interval Closure
Arm Type
Active Comparator
Arm Title
Arthoscopic Bankart Repair alone
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Arthroscopic Bankart Repair alone
Intervention Description
Usual arthroscopic Bankart repair
Intervention Type
Procedure
Intervention Name(s)
Closure of rotator interval
Intervention Description
Usual arthroscopic Bankart repair plus rotator cuff interval closure
Primary Outcome Measure Information:
Title
Western Ontario Shoulder Instability Index
Description
Disease-specific quality of life measurement tool (21 questions, 4 domains)
Time Frame
3,6 weeks;3,6 months; 1,2 years
Secondary Outcome Measure Information:
Title
Range of Motion
Description
Universal goniometer
Internal & external ROM at neutral (0°) and 90° of abduction
Both active and passive ROM at both positions
Time Frame
3,6 months; 1-2 years
Title
4-Item Pain Intensity Measure
Description
Pain intensity in the morning, afternoon, evening and with activity
Time Frame
3,6, weeks; 3, 6 months; 1,2 years
Title
Upper Extremity Functional Index
Description
Limb-specific quality of life measurement tool (20 questions)
Time Frame
3,6 weeks; 3,6 months; 1,2 years
Title
Recurrence
Description
Patient-reported re-dislocation
Time Frame
3,6 weeks; 3,6 months; 1,2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dianne Bryant, PhD
Phone
5196612111
Ext
83947
Email
dianne.bryant@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianne Bryant, PhD
Organizational Affiliation
The University of Western Ontario
Official's Role
Study Director
Facility Information:
Facility Name
London Health Sciences Centre - Unviersity Hospital
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Litchfield, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Kevin Willits, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Marie Eve LeBel, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Dianne Bryant, PhD
First Name & Middle Initial & Last Name & Degree
Tyler Groves, BSc
12. IPD Sharing Statement
Learn more about this trial
The Role of Rotator Interval Closure in Bankart Lesion Repair
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