Shoulder instability Trial comparing Arthroscopic stabilization Benefits compared with Latarjet procedure Evaluation (STABLE)

Conditions: Shoulder dislocation
Shoulder instability
10023213

Registration Number: NL-OMON50962

Lead Sponsor: McMaster University, department of Surgery

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Men and women ages 18-50 years;
2. Diagnosis of post-traumatic recurrent anterior dislocation. This will
require a minimum of 2 episodes of documented dislocations 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. Mild glenoid bone loss as defined on CT by standardized and reproducible
best-fit circle technique (>10% but <20%);
4. Provision of informed consent.

Exclusion Criteria

1. Patients with concomitant injuries (cuff tear);
2. Previous shoulder surgery;
3. Patients that will likely have problems, in the judgment of the
investigators, with maintaining follow-up;
4. Epilepsy;
5. Patients who are or at risk of being incarcerated;
6. Diagnosis of multidirectional instability;
7. Cases involving litigation or workplace insurance claims (e.g. WSIB);
8. Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton
hypermobility score >6.
9. Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the pilot study will be a composite measure of<br /><br>feasibility, including:<br /><br>1) Recruitment (number of patients recruited at each site during a 10-month<br /><br>period),<br /><br>2) Protocol adherence (number of errors in randomization); and<br /><br>3) Follow-up (proportion of participants followed at two years).<br /><br>We hypothesize that our feasibility outcomes will meet a priori criteria<br /><br><br /><br>The success of the pilot study will be based upon the following a priori<br /><br>thresholds:<br /><br>1) 82 patients recruited within 10 months,<br /><br>2) 3 or fewer errors in randomization across the 82 enrolled patients and<br /><br>treatment adherence in a minimum 66 of 82 participants (80%), and<br /><br>3) 70 of 82 participants (85%) achieving complete follow-up at two years.</p><br>

Secondary Outcome Measures