Shoulder dislocation
Conditions
Interventions
Participants will undergo arthroscopic soft tissue stabilization (Bankart
procedure) or non-surgical treatment as described below.
Arthroscopic Stabilization (Intervention)
Patients randomized to su
Sponsors
McMaster University
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients ages 18-40 years; 2. Diagnosis of first-time anterior shoulder dislocation having occurred within the past 3 months, confirmed either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms; 3. Provision of informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients that cannot undergo surgery or anesthesia; 2. Patients with concomitant injuries (rotator cuff tear, fracture); 3. Previous shoulder surgery; 4. Patients that will likely have problems with maintaining follow-up or are incarcerated; 5. Epilepsy/seizure disorder 6. Pregnancy; 7. Diagnosis of multidirectional instability; 8. Bony glenoid defect (bony Bankart) >10% as measured on preop imaging; 9. Dislocation without trauma, in a context of hyper laxity or atraumatic instability; 10. Cases involving litigation or workplace insurance claims (e.g. WSIB).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success of the pilot study will be based upon the following a priori thresholds: 1. 50 patients recruited within 10 months; 2. 42 of 50 participants (85%) achieving complete follow-up at two years; 3. 85% of patients allocated to surgical intervention receiving surgery within 3 months of enrollment; 4. Less than 5 crossovers* between both groups. *Note: Crossovers are defined as either: 1) participants randomized to non-operative management (control group) who choose to undergo surgery in the absence of any feelings of recurrent instability or re-dislocation; or 2) participants randomized to surgical intervention who opt out of surgery prior to surgical intervention and choose to undergo primary non-operative management. We will confirm feasibility with a *traffic light* approach to determine if the definitive trial will be feasible, require modifications or will not be feasible. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the pilot trial will be the clinical objectives of the definitive trial: 1. Rates of recurrent shoulder dislocations up to 24 months* post-treatment; 2. Symptoms of instability without dislocation up to 24 months post treatment; 3. Clinical outcomes measured by Western Ontario Shoulder Instability (WOSI) Index, American Shoulder and Elbow Society (ASES) score, Shoulder Activity Scale, EQ-5D, Visual Analog Scale (VAS) Pain Score, and Patient Satisfaction questionnaire; 4. Physical examination: range of motion, strength, stability; 5. Return to previous level of activity and work, and; 6. Safety, shoulder-related complications and serious adverse events. Hypothesis: We believe that the pilot trial will be feasible in our ability to recruit participants rapidly and meet our feasibility objectives. | — |
Countries
Canada, Kuwait, Netherlands, Spain, United States
Contacts
Public ContactS.N.W. Vorrink
OLVG
Outcome results
None listed