The Role of Rotator Interval Closure in Bankart Lesion Repair

NCT ID: NCT01620619

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28

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?

Conditions

Bankart Lesions; Anterior Shoulder Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arthroscopic Bankart Repair & Rotator Interval Closure

Group Type: ACTIVE_COMPARATOR

Closure of rotator interval

Intervention Type: PROCEDURE

Usual arthroscopic Bankart repair plus rotator cuff interval closure

Arthoscopic Bankart Repair alone

Group Type: ACTIVE_COMPARATOR

Arthroscopic Bankart Repair alone

Intervention Type: OTHER

Usual arthroscopic Bankart repair

Interventions

Arthroscopic Bankart Repair alone

Usual arthroscopic Bankart repair

Intervention Type: OTHER

Closure of rotator interval

Usual arthroscopic Bankart repair plus rotator cuff interval closure

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: lead

Responsible Party

Dianne Bryant

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dianne Bryant, PhD

Role: STUDY_DIRECTOR

The University of Western Ontario

Locations

London Health Sciences Centre - Unviersity Hospital

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Dianne Bryant, PhD

Role: CONTACT

dianne.bryant@uwo.ca

5196612111 ext. 83947

Other Identifiers

FKSMC 2010 - 4

Identifier Type: -

Identifier Source: org_study_id