Overview
This randomized controlled trial seeks to address a significant clinical gap by evaluating the outcomes of two postoperative immobilization methods following arthroscopic soft tissue surgery for anterior shoulder instability: a standard static arm sling and a dynamic shoulder orthosis.
Description
The present study is a pilot trial that aims to compare outcomes between patients immobilized using a standard arm sling and those managed with a dynamic shoulder orthosis (specifically, the medi® Shoulder action brace) following arthroscopic soft tissue stabilization for anterior shoulder instability. This trial will evaluate the impact of these two immobilization methods on early shoulder function, pain, recurrence, and patient satisfaction, while primarily assessing the feasibility of a future definitive trial. This is a prospective, single-center, pilot randomized controlled trial with parallel groups. Participants will be allocated in a 1:1 ratio to either the dynamic orthosis or the standard sling. The trial seeks to determine whether dynamic immobilization designed to facilitate controlled activity offers measurable advantages in early function, comfort, or recurrence risk compared to standard arm slings.
Eligibility
Inclusion Criteria:
- Adults aged ≥18 years undergoing arthroscopic soft-tissue stabilization for anterior shoulder instability (Bankart repair ± Hill-Sachs remplissage).
- Ability and willingness to comply with the study protocol and scheduled follow-ups.
- Provision of written informed consent.
Exclusion Criteria:
- Significant glenoid bone loss requiring bony augmentation procedures (e.g., bone block procedures, Latarjet).
- Concomitant rotator cuff repair or fracture fixation.
- Contraindication to MRI (e.g., pacemaker, claustrophobia, incompatible implants).
- Cognitive impairment, language barriers, or logistical inability to attend follow-up visits.
- Previous ipsilateral shoulder surgery.
