Sling vs. Dynamic Shoulder Stabilizer After Soft Tissue Shoulder Instability Surgery (SLIDY)

NCT07644624 | Not Yet Recruiting

• 1 other identifier: ICPS037/25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Instability; Shoulder Dislocation; Anterior Shoulder Instability

Keywords

Arthroscopic Bankart Repair; Hill-Sachs Remplissage; Dynamic Shoulder Orthosis; Postoperative Immobilization; Shoulder Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Feasibility composite (Recruitment, Retention, and Adherence)

  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.

  Up to 12 months post-surgery.

Secondary Outcomes (7)

• Western Ontario Shoulder Instability Index (WOSI)

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.

• Rowe Score

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.

• Constant-Murley Score

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.

• Subjective Shoulder Value (SSV)

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.

• Range of Motion (ROM)

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.

Study Arms (2)

Dynamic Immobilizer

EXPERIMENTAL

Continuous wear of the dynamic shoulder orthosis for 3 weeks post-surgery, followed by a standardized physiotherapy protocol.

Device: Dynamic Immobilizer

Standard Arm Sling

ACTIVE COMPARATOR

Continuous wear of a conventional fabric arm sling for 3 weeks post-surgery, followed by a standardized physiotherapy protocol.

Device: Conventional fabric arm sling

Interventions

Dynamic Immobilizer DEVICE

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.

Also known as: medi® Shoulder action brace

Dynamic Immobilizer

Conventional fabric arm sling DEVICE

Static immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks.

Standard Arm Sling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Bellvitge University Hospital

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Abdul-ilah Hachem, MD

  Head of the Shoulder Unit, Department of Orthopaedics, Bellvitge Univeristy Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul-ilah Hachem, MD

CONTACT

+34609406030; abelhachem@gmail.com

Hady Ezzeddine, MD

CONTACT

hadyezz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Shoulder Surgery Unit, Department of Orthpaedic Surgery

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)