Anterior Shoulder Instability, Bankart Lesions
Conditions
Keywords
Shoulder, Bankart, Anterior Instability, Rotator Cuff
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?
Interventions
OTHERArthroscopic Bankart Repair alone
Usual arthroscopic Bankart repair
PROCEDUREClosure of rotator interval
Usual arthroscopic Bankart repair plus rotator cuff interval closure
Sponsors
University of Western Ontario, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 51 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Shoulder Instability Index | 3,6 weeks;3,6 months; 1,2 years | Disease-specific quality of life measurement tool (21 questions, 4 domains) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 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 | 3,6, weeks; 3, 6 months; 1,2 years | Pain intensity in the morning, afternoon, evening and with activity |
| Upper Extremity Functional Index | 3,6 weeks; 3,6 months; 1,2 years | Limb-specific quality of life measurement tool (20 questions) |
| Recurrence | 3,6 weeks; 3,6 months; 1,2 years | Patient-reported re-dislocation |
Countries
Canada
Contacts
Primary ContactDianne Bryant, PhD
Outcome results
None listed