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Recruiting NCT07644624

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

No phase Interventional Anterior Shoulder Instability Shoulder Instability Shoulder Dislocation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dynamic Immobilizer, Conventional fabric arm sling.
Who it may be relevant to
Registry conditions: Anterior Shoulder Instability, Shoulder Instability, Shoulder Dislocation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

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

Primary outcome measures

  • Feasibility composite (Recruitment, Retention, and Adherence) [Time frame: Up to 12 months post-surgery.]
Secondary outcome measures (7)
  • Western Ontario Shoulder Instability Index (WOSI) [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.]
  • Rowe Score [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.]
  • Constant-Murley Score [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.]
  • Subjective Shoulder Value (SSV) [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.]
  • Range of Motion (ROM) [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.]
  • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.]
  • MRI Evaluation of Structural Healing [Time frame: Between 6 and 12 months post-surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Bellvitge University Hospital — L'Hospitalet de Llobregat

Identifiers

NCT: NCT07644624 · ICPS037/25 · ICPS037/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗