Multicentre Randomised Controlled Trial on Shoulder Instability (STABLE): Study Overview
Introduction
Recurrent shoulder dislocations can damage the labrum and lead to bone loss in the shoulder. There are two main treatment options: soft tissue repair and bone augmentation. However, the best treatment for patients with some bone loss is still unclear, and current practices vary widely.
Methods and Analysis
The STABLE trial is an ongoing study involving 114 patients with recurrent shoulder instability and minor bone loss (10%-20%). Participants will be randomly assigned to one of two treatments:
- Arthroscopic Capsuloligamentous Repair: Bankart repair combined with remplissage.
- Latarjet Procedure: Open or arthroscopic coracoid transfer.
The main goal is to compare the effectiveness of these treatments over 24 months, measured by the Western Ontario Shoulder Instability Index. Other important outcomes include:
- Rates of recurrent dislocations and instability symptoms.
- Clinical outcomes assessed by various scores.
- Physical examination results (range of motion, stability).
- Return to previous activity or sports.
- Rate of complications and serious adverse events.
Ethics and Dissemination
This trial has received ethical approval from the Hamilton Integrated Research Ethics Board (HiREB). Study results will be published in a peer-reviewed journal, regardless of the significance of the findings.
Trial Registration
Trial registration number: NCT05705479. This study is registered on clinicaltrials.gov.
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