An interventional study of Dynamic Immobilizer and Conventional fabric arm sling in Anterior Shoulder Instability, Shoulder Instability and Shoulder Dislocation, sponsored by Hospital Universitari de Bellvitge. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →Hospital Universitari de Bellvitge is the lead sponsor of 120 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continuous wear of the dynamic shoulder orthosis for 3 weeks post-surgery, followed by a standardized physiotherapy protocol.
Device: Dynamic Immobilizer
Continuous wear of a conventional fabric arm sling for 3 weeks post-surgery, followed by a standardized physiotherapy protocol.
Device: Conventional fabric arm sling
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
Static immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks.
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.
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.
Rowe Score
Clinical assessment of shoulder stability, mobility, and function.
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
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.
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.
Range of Motion (ROM)
Active and passive flexion, abduction, and rotation measured via standardized goniometry by two blinded assessors.
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Patient-reported outcome measure assessing physical function, symptoms, and related quality of life of the upper extremity.
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
MRI Evaluation of Structural Healing
Assessment of capsulolabral integrity and bone defect remodeling, scored as intact, partial, or re-tear by two blinded physicians.
Time frame: Between 6 and 12 months post-surgery.
Plan to share: No — Data will be anonymized and stored in encrypted institutional servers in accordance with GDPR and HIPAA regulations. No data will be transferred to third parties outside the study team.
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