The Role of Rotator Interval Closure in Bankart Lesion Repair

N/AUnknownNCT01620619

University of Western Ontario, Canada142 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

142

Conditions

Bankart Lesions Anterior Shoulder Instability

Interventions

Arthroscopic Bankart Repair aloneOTHER

Usual arthroscopic Bankart repair

Closure of rotator intervalPROCEDURE

Usual arthroscopic Bankart repair plus rotator cuff interval closure

Eligibility

Sex: ALLMin age: 15 YearsMax age: 51 Years

Medical Language ↔ Plain English

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)

Locations (1)

London Health Sciences Centre - Unviersity Hospital

London, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Western Ontario Shoulder Instability Index

Disease-specific quality of life measurement tool (21 questions, 4 domains)

Time frame: 3,6 weeks;3,6 months; 1,2 years

Secondary Outcomes

Range of Motion

* Universal goniometer * Internal \& external ROM at neutral (0°) and 90° of abduction * Both active and passive ROM at both positions

Time frame: 3,6 months; 1-2 years

4-Item Pain Intensity Measure

Pain intensity in the morning, afternoon, evening and with activity

Time frame: 3,6, weeks; 3, 6 months; 1,2 years

Upper Extremity Functional Index

Limb-specific quality of life measurement tool (20 questions)

Time frame: 3,6 weeks; 3,6 months; 1,2 years

Recurrence

Patient-reported re-dislocation

Time frame: 3,6 weeks; 3,6 months; 1,2 years

Central Contacts

Dianne Bryant, PhD

CONTACT

5196612111 dianne.bryant@uwo.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.