NCT Number: NCT07644624
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Location status: Recruiting
Abdul-ilah Hachem, MD
CONTACT
Abdul-ilah Hachem, MD
PRINCIPAL_INVESTIGATOR
Hady Ezzeddine, MD
CONTACT
Hady Ezzeddine, MD
SUB_INVESTIGATOR
Xavi Rius, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: medi® Shoulder action brace
Static immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks.
Time frame: 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.
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
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.
Clinical assessment of shoulder stability, mobility, and function.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Abdul-ilah Hachem, MD
CONTACT
Hady Ezzeddine, MD
CONTACT
Hospital Universitari de Bellvitge
Other
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
Acronym: SLIDY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05431114
Anterior Shoulder Instability, Glenoid; Dislocation
Durham, North Carolina, United States
View Trial DetailsNCT07457931
Anterior Shoulder Dislocation, Anterior Shoulder Instability
Madrid, Spain
View Trial DetailsNCT07715162
Anterior Shoulder Instability
View Trial DetailsNCT03985839
Acetabular Labrum Tear, Anterior Shoulder Instability
Aurora, Colorado, United States
View Trial Details