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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
Static immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks.
Bellvitge University Hospital
L'Hospitalet de Llobregat, Catalonia, Spain
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.
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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.