Sling vs. Dynamic Shoulder Stabilizer After Soft Tissue Shoulder Instability Surgery ("SLIDY"): A Pilot Randomized Controlled Trial Assessing Feasibility, Early Functional Recovery, and Structural Healing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Dynamic Immobilizer
Continuous wear of the dynamic shoulder orthosis for 3 weeks post-surgery, followed by a standardized physiotherapy protocol.
Intervention: Dynamic Immobilizer (Device)
Standard Arm Sling
Continuous wear of a conventional fabric arm sling for 3 weeks post-surgery, followed by a standardized physiotherapy protocol.
Intervention: Conventional fabric arm sling (Device)
Investigators
Abdul-ilah Hachem
Head of the Shoulder Surgery Unit, Department of Orthpaedic Surgery
Hospital Universitari de Bellvitge