The Role of Rotator Interval Closure in Bankart Lesion Repair
1 other identifier
interventional
142
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedApril 25, 2014
April 1, 2014
6.2 years
June 4, 2012
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Western Ontario Shoulder Instability Index
Disease-specific quality of life measurement tool (21 questions, 4 domains)
3,6 weeks;3,6 months; 1,2 years
Secondary Outcomes (4)
Range of Motion
3,6 months; 1-2 years
4-Item Pain Intensity Measure
3,6, weeks; 3, 6 months; 1,2 years
Upper Extremity Functional Index
3,6 weeks; 3,6 months; 1,2 years
Recurrence
3,6 weeks; 3,6 months; 1,2 years
Study Arms (2)
Arthroscopic Bankart Repair & Rotator Interval Closure
ACTIVE COMPARATORArthoscopic Bankart Repair alone
ACTIVE COMPARATORInterventions
Usual arthroscopic Bankart repair
Usual arthroscopic Bankart repair plus rotator cuff interval closure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre - Unviersity Hospital
London, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dianne Bryant, PhD
The University of Western Ontario
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 15, 2012
Study Start
February 1, 2010
Primary Completion
May 1, 2016
Last Updated
April 25, 2014
Record last verified: 2014-04