Shoulder Dislocation Clinical Trial
Official title:
Arthroscopic Bankart Repair and Remplissage Versus Latarjet Coracoid Transfer for Recurrent Anterior Glenohumeral Instability With Subcritical Bone Loss - A Randomized Controlled Trial
This is a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer for the treatment of recurrent anterior glenohumeral instability with subcritical bone loss.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 60 Years |
Eligibility | Inclusion Criteria: - anterior shoulder instability (>1 dislocation) - age >14 years - evidence of a Hill-Sachs defect on MRI or CT, - < 20% anteroposterior glenoid bone loss Exclusion Criteria: - >20% anteroposterior glenoid bone loss - significant shoulder comorbidities (i.e., osteoarthritis, previous surgery other than previous instability), active joint or systemic infection, significant muscle paralysis, rotator cuff or Charcot's arthropathy, - significant medical comorbidity that may alter effectiveness of surgical intervention - major medical illness, - unable to speak French or English, - psychiatric illness that precludes informed consent, - unwilling to be followed for 2 years |
Country | Name | City | State |
---|---|---|---|
Canada | Fowler Kennedy Sport Medicine Clinic | London | Ontario |
Canada | Pan Am Clinic | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada | Panam Clinic |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Western Ontario Shoulder Instability (WOSI) Score | Western Ontario Shoulder Instability (WOSI) questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op and post-op WOSI score as a covariate.
This questionnaire has 21 questions, each scored on a scale from 0 to 100, with 0 being the best score (no limitations related to the shoulder) and 100 representing the worst score. Overall, the questionnaire is scored as a percentage of the maximum score of 2100 points. There are subscale components reporting on: physical symptoms (questions 1 through 10; maximum score of 1000); sports/recreation/work (questions 11 through 14; maximum score 400); lifestyle (questions 15 through 18; maximum score 400); and emotion (questions 19-21; maximum score 300). Subscale scores are added to determine the total score out of a possible 2100 points, with 2100, or 100%, representing the worst possible score. |
24 months | |
Secondary | Pain numeric rating scale (NRS) | This tool is designed to evaluate pain. The Scale is from 0-100 to determine shoulder pain pre and post-operatively; 0=extreme pain, 100=no pain | 24 months | |
Secondary | Simple Shoulder Test (SST) | Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. Differences between study arm outcomes will be assessed using pre-op SST scores as a covariate | 24 months | |
Secondary | American Shoulder and Elbow Society (ASES) assessment | The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function. Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate | 24 months | |
Secondary | Range of motion | Range of motion will be evaluated using a goniometer to calculate: forward flexion, abduction, external rotation and internal rotation | 24 months | |
Secondary | Post-operative complications | Post-surgical complications will be collected including: neurologic injury (neuropraxia); superficial wound infection; deep surgical site infection; coracoid non-union or malunion; posterior shoulder pain; stiffness; recurrent instability | 24 months |
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