The Role of Rotator Interval Closure in Bankart Lesion Repair

Study Overview
=================
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?

Official Title
-----------------
The Role of Rotator Interval Closure in Bankart Lesion Repair

Conditions
-----------------
Bankart Lesions, Anterior Shoulder Instability

Intervention / Treatment
-----------------
* Other: Arthroscopic Bankart Repair alone
* Procedure: Closure of rotator interval


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 51 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthroscopic Bankart Repair & Rotator Interval Closure<br> | Procedure: Closure of rotator interval<br>* Usual arthroscopic Bankart repair plus rotator cuff interval closure<br>|
| Active Comparator: Arthoscopic Bankart Repair alone<br> | Other: Arthroscopic Bankart Repair alone<br>* Usual arthroscopic Bankart repair<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Universal goniometer Internal & external ROM at neutral (0°) and 90° of abduction Both active and passive ROM at both positions | 3,6 months; 1-2 years | 
| 4-Item Pain Intensity Measure | Pain intensity in the morning, afternoon, evening and with activity | 3,6, weeks; 3, 6 months; 1,2 years | 
| Upper Extremity Functional Index | Limb-specific quality of life measurement tool (20 questions) | 3,6 weeks; 3,6 months; 1,2 years | 
| Recurrence | Patient-reported re-dislocation | 3,6 weeks; 3,6 months; 1,2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder, Bankart, Anterior Instability, Rotator Cuff