Active — Not RecruitingNot Applicable

Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation - STABLE Definitive Trial

Canada114 participantsStarted 2023-10-17

Plain-language summary

The primary objective of the study is to evaluate the functional shoulder recovery of patients with recurrent shoulder dislocations at 24 months when treated with either arthroscopic capsuloligamentous repair (Bankart Procedure +/- Remplissage) or coracoid transfer (Latarjet procedure).

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. Adults ages 18-50 years;
✓. 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;
✓. Subcritical glenoid bone loss as defined on CT by standardized and reproducible best-fit circle technique (\>10% but \<20%);
✓. Provision of informed consent.

Exclusion criteria

✕. Patients with concomitant injuries of the index shoulder (cuff tear, greater tuberosity fracture);
✕. Previous shoulder surgery;
✕. Patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
✕. Epilepsy/seizure disorder;
✕. Patients who are currently incarcerated;
✕. Diagnosis of multidirectional instability;
✕. Cases involving litigation or workplace insurance claims (e.g. WSIB);
✕. Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score \> 6.

What they're measuring

Clinical Outcome - Shoulder function

Timeframe: 2 years

Trial details

NCT IDNCT05705479

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

View on ClinicalTrials.gov More Shoulder Dislocation trials