Dynamic Immobilizer: An adjustable strap system applied immediately post-surgery that permits movement of the shoulder joint while simultaneously limiting potentially harmful ranges of motion and translations. It is worn continuously for 3 weeks.
Conventional fabric arm sling: Static immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Feasibility composite (Recruitment, Retention, and Adherence) — Up to 12 months post-surgery. Evaluation of the feasibility of conducting a definitive randomized controlled trial by measuring the recruitment rate (percentage of eligible enrolled), retention/follow-up completion rates, and protocol adherence (self-reported and therapist-verified). Safety and device-related adverse events will also be recorded.
Trial sites (1)
Facility
City
Region
Status
Bellvitge University Hospital
L'Hospitalet de Llobregat
Catalonia
Recruiting
More Hospital Universitari de Bellvitge trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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