Recruiting

Rotator Interval Closure

Sponsor:

University of Western Ontario, Canada

Code:

NCT01620619

Conditions

Bankart Lesions

Anterior Shoulder Instability

Eligibility Criteria

Sex: All

Age: 15 - 51

Healthy Volunteers: Not accepted

Interventions

Arthroscopic Bankart Repair alone

Closure of rotator interval

Study Details

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

Conditions

Bankart Lesions

Anterior Shoulder Instability

Study ID

NCT01620619

Start date

Feb, 2010

Status verified date

Apr, 2014

Primary completion date

May, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 51

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arthroscopic Bankart Repair & Rotator Interval Closure

active comparator: Arthoscopic Bankart Repair alone

Interventions

Arthroscopic Bankart Repair alone

Usual arthroscopic Bankart repair

Closure of rotator interval

Usual arthroscopic Bankart repair plus rotator cuff interval closure

Primary outcome measure

  • Western Ontario Shoulder Instability Index [ Time Frame: 3,6 weeks;3,6 months; 1,2 years ]

Central Contacts and Locations

Central contacts

Dianne Bryant, PhD

5196612111dianne.bryant@uwo.ca

Locations

London Health Sciences Centre - Unviersity Hospital

Recruiting

London, Ontario, Canada

Principal Investigator:

Robert Litchfield, MD, FRCSC

More Information

Sponsor

University of Western Ontario, Canada

Last update posted

Apr 25, 2014

Last verified

Apr, 2014

Keywords

  • Shoulder
  • Bankart
  • Anterior Instability
  • Rotator Cuff

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Western Ontario, Canada on 2014-04-25.