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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01620619
Other study ID # FKSMC 2010 - 4
Secondary ID
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. completion date
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


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
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