Surgical Treatment of Recurrent Shoulder Dislocations
ConditionShoulder Instability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorNova Scotia Health Authority
About this trial
This is a pilot multi-centre, double blinded randomized controlled trial. The primary outcome of this pilot trial will be feasibility. Prior to conducting a large definitive trial, the investigators will conduct this pilot trial comparing arthroscopic Bankart repair with arthroscopic anatomic glenoid reconstruction (AAGR), evaluating recurrent dislocation rates and functional outcomes over a 24-month period. The feasibility objectives are: (1) to evaluate the investigators ability to recruit patients across multiple sites and (2) to assess study protocol adherence and ability to follow patients to 24 months. Clinical objectives for the pilot trial are exploratory only. The investigators wish to gather means and standard deviations for clinical outcomes to power their future definitive trial. The objectives of the definitive trial will include a comparison of patient-reported outcomes at the two-year post-operative time point, differences in recurrence rates, complication rates, functional shoulder assessments, and return to work/sport.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Recurrent anterior glenohumeral dislocation (two or more incidents)
Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI)
Disqualifiers
Uncontrolled diabetes (Hgb A1C >7%)
Prior surgery of affected shoulder
Pregnancy
Multidirectional instability
Trial design
Design model
Parallel
Treatments tested in this trial
Bankart Repair
Procedure/SurgeryPatients Randomized to Bankart Repair Group
Anatomic Glenoid Reconstruction
Procedure/SurgeryPatients Randomized to Anatomic Glenoid Reconstruction Group
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Bankart RepairActive comparator 1 intervention
Group B: Anatomic Glenoid ReconstructionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Subject Recruitment
Recruitment of 100 participants
Time frame
Measured throughout the entire study, up to 2 years2
Participant Adherence
Protocol adherence
Time frame
Measured throughout the entire study, up to 2 years3
Patient Follow-up
Proportion of Patients Followed at 24 months
Time frame
Measured throughout the entire study, up to 2 yearsSecondary outcomes
1
The Western Ontario Shoulder Instability Index (WOSI)
This questionnaire is used to measure shoulder related quality of life in the participants. The range of possible scores is 0-100, with 0 representing no deficits and 100 representing the worst deficits.
Time frame
Measured at 6 month, 1 year, and 2 year time points2
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form
This questionnaire is used to evaluate shoulder function, the possible range of scores is 0-100, with 0 representing the best score and 100 representing the worst score.
Time frame
Measured at 6 month, 1 year, and 2 year time points3
Disabilities of the Arm, Shoulder, and Hand (DASH)
This is a questionnaire used to measure the physical function of the participants, scores range from 0-100 with 0 being the best score and 100 being the worst score possible.
Time frame
Measured at 6 month, 1 year, and 2 year time points4
MARX Physical Activity Questionnaire
This questionnaire is used to assess the physical activity status of the participants, the possible scores range from 0-16 with 16 being the best possible score.
Time frame
Measured at 6 month, 1 year, and 2 year time pointsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nova Scotia Health Authority
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
NYU Langone Health
Collaborator
Panam Clinic
Collaborator
Vancouver Coastal Health
Collaborator
University of British Columbia
Collaborator
Ottawa Hospital Research Institute
Collaborator
Children's Hospital of Eastern Ontario Research Institute
Collaborator
Horizon Health Network
Collaborator
Research St. Joseph's - Hamilton
Collaborator
London Health Sciences Centre Research Institute
Collaborator
University of Utah
Collaborator
Orlando Health, Inc.
Collaborator
TSAOG Orthopaedics and Spine
Collaborator
The Hawkins Foundation
Collaborator
Source ClinicalTrials.gov