The Role of Rotator Interval Closure in Bankart Lesion Repair

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

Study Overview

• Status: Unknown
• Conditions: Bankart Lesions; Anterior Shoulder Instability
• Intervention / Treatment: Procedure: Closure of rotator interval; Other: Arthroscopic Bankart Repair alone

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?

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • Recruiting
      • London Health Sciences Centre - Unviersity Hospital
      • Principal Investigator: Robert Litchfield, MD, FRCSC
      • Sub-Investigator: Marie Eve LeBel, MD, FRCSC
      • Sub-Investigator: Tyler Groves, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 51 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arthroscopic Bankart Repair & Rotator Interval Closure	Procedure: Closure of rotator interval; Usual arthroscopic Bankart repair plus rotator cuff interval closure
ACTIVE_COMPARATOR: Arthoscopic Bankart Repair alone	Other: Arthroscopic Bankart Repair alone; Usual arthroscopic Bankart repair

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

Collaborators and Investigators

• Sponsor: University of Western Ontario, Canada

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ANTICIPATED): May 1, 2016

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (ESTIMATE): June 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 25, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Shoulder; Rotator Cuff; Bankart; Anterior Instability
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Shoulder Fractures; Bankart Lesions
• Other Study ID Numbers: FKSMC 2010 - 4