The Role of Rotator Interval Closure in Bankart Lesion Repair

Anterior Shoulder Instability Clinical Trial

Official title:

The Role of Rotator Interval Closure in Bankart Lesion Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01620619
• Other study ID #: FKSMC 2010 - 4
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2012
• Last updated: April 24, 2014
• Start date: February 2010

Study information

• Verified date: April 2014
• Source: University of Western Ontario, Canada
• Contact: Dianne Bryant, PhD
• Phone: 5196612111
• Email: dianne.bryant[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 51 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Shoulder Instability
• Bankart Lesions

Intervention

Other:
• Arthroscopic Bankart Repair alone
Usual arthroscopic Bankart repair

Procedure:
• Closure of rotator interval
Usual arthroscopic Bankart repair plus rotator cuff interval closure

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - Unviersity Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	4-Item Pain Intensity Measure	Pain intensity in the morning, afternoon, evening and with activity	3,6, weeks; 3, 6 months; 1,2 years	No
Secondary	Upper Extremity Functional Index	Limb-specific quality of life measurement tool (20 questions)	3,6 weeks; 3,6 months; 1,2 years	No
Secondary	Recurrence	Patient-reported re-dislocation	3,6 weeks; 3,6 months; 1,2 years	No