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| ID | Type | Description | Link |
|---|---|---|---|
| ICPS037/25 | Other Identifier | Bellvitge Hospital Institutional Review Board (CEIm) |
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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 mediĀ® 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Immobilizer | Experimental | Continuous wear of the dynamic shoulder orthosis for 3 weeks post-surgery, followed by a standardized physiotherapy protocol. |
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| Standard Arm Sling | Active Comparator | Continuous wear of a conventional fabric arm sling for 3 weeks post-surgery, followed by a standardized physiotherapy protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario Shoulder Instability Index (WOSI) | Patient-reported functional outcome assessing quality of life related to shoulder instability. | Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months. |
| Rowe Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdul-ilah Hachem, MD | Contact | +34609406030 | abelhachem@gmail.com | |
| Hady Ezzeddine, MD | Contact | hadyezz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Abdul-ilah Hachem, MD | Head of the Shoulder Unit, Department of Orthopaedics, Bellvitge Univeristy Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellvitge University Hospital | Recruiting | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
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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| ID | Term |
|---|---|
| D012783 | Shoulder Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| Conventional fabric arm sling | Device | Static immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks. |
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Clinical assessment of shoulder stability, mobility, and function.
| 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. | 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. | 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. | 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. | 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. | Between 6 and 12 months post-surgery. |
| D000070599 |
| Shoulder Injuries |