The Role of Rotator Interval Closure in Bankart Lesion Repair

University of Western Ontario, Canada

Status: Unknown

Conditions: Anterior Shoulder Instability; Bankart Lesions

Treatments: Other: Arthroscopic Bankart Repair alone; Procedure: Closure of rotator interval

Study type: Interventional

Funder types: Other

Identifiers

NCT01620619

FKSMC 2010 - 4

Details and patient eligibility

About

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

Full 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?

Enrollment: 142 estimated patients

Sex: All

Ages: 15 to 51 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 2 patient groups

Arthroscopic Bankart Repair & Rotator Interval Closure

Active Comparator group

Treatment:

Procedure: Closure of rotator interval

Arthoscopic Bankart Repair alone

Active Comparator group

Treatment:

Other: Arthroscopic Bankart Repair alone