Anterior Shoulder Instability, Shoulder Dislocation, Shoulder Instability
Conditions
Keywords
Arthroscopic Bankart Repair, Hill-Sachs Remplissage, Dynamic Shoulder Orthosis, Postoperative Immobilization, Shoulder Rehabilitation
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.
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
DEVICEDynamic 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.
DEVICEConventional fabric arm sling
Static immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks.
Sponsors
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility composite (Recruitment, Retention, and Adherence) | Up to 12 months post-surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Shoulder Instability Index (WOSI) | Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months. | Patient-reported functional outcome assessing quality of life related to shoulder instability. |
| Rowe Score | Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months. | Clinical assessment of shoulder stability, mobility, and function. |
| Constant-Murley Score | Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months. | Clinical assessment of general shoulder function, including pain, activities of daily living, range of motion, and strength. |
| Subjective Shoulder Value (SSV) | Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months. | Patient-reported subjective function of the shoulder expressed as a percentage of a normal shoulder. |
| Range of Motion (ROM) | Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months. | Active and passive flexion, abduction, and rotation measured via standardized goniometry by two blinded assessors. |
| Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score | Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months. | Patient-reported outcome measure assessing physical function, symptoms, and related quality of life of the upper extremity. |
| MRI Evaluation of Structural Healing | Between 6 and 12 months post-surgery. | Assessment of capsulolabral integrity and bone defect remodeling, scored as intact, partial, or re-tear by two blinded physicians. |
Countries
Spain
Contacts
CONTACTAbdul-ilah Hachem, MD
CONTACTHady Ezzeddine, MD
PRINCIPAL_INVESTIGATORAbdul-ilah Hachem, MD
Head of the Shoulder Unit, Department of Orthopaedics, Bellvitge Univeristy Hospital
Outcome results
None listed