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

ConditionsAnterior Shoulder InstabilityShoulder InstabilityShoulder Dislocation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Conventional fabric arm sling

    Device

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Dynamic ImmobilizerExperimental treatment 1 intervention
Group B: Standard Arm SlingActive comparator 1 intervention

Trial outcomes

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.

Time frame
Up to 12 months post-surgery.

Secondary outcomes

1

Western Ontario Shoulder Instability Index (WOSI)

Patient-reported functional outcome assessing quality of life related to shoulder instability.

Time frame
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
2

Rowe Score

Clinical assessment of shoulder stability, mobility, and function.

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

Constant-Murley Score

Clinical assessment of general shoulder function, including pain, activities of daily living, range of motion, and strength.

Time frame
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
4

Subjective Shoulder Value (SSV)

Patient-reported subjective function of the shoulder expressed as a percentage of a normal shoulder.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitari de Bellvitge

Lead sponsor

Source ClinicalTrials.gov
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