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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
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroscopic Bankart Repair & Rotator Interval Closure | Active Comparator |
| |
| Arthoscopic Bankart Repair alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic Bankart Repair alone | Other | Usual arthroscopic Bankart repair |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion |
| 3,6 months; 1-2 years |
| 4-Item Pain Intensity Measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dianne Bryant, PhD | Contact | 5196612111 | 83947 | dianne.bryant@uwo.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dianne Bryant, PhD | The University of Western Ontario | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre - Unviersity Hospital | Recruiting | London | Ontario | Canada |
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| ID | Term |
|---|---|
| D000070896 | Bankart Lesions |
| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| Closure of rotator interval | Procedure | Usual arthroscopic Bankart repair plus rotator cuff interval closure |
|
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 |