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Active Not Recruiting NCT07892729

Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage

Conditions: Anterior Shoulder Instability

Sex: All
Ages: 15 Years – N/A
Healthy volunteers: No
Enrollment: 41
Sponsor: Omniartro Lda

Location: Hospital dos SAMS de Lisboa Lisbon Europe

Summary

The goal of this observational study is to evaluate clinical, functional, and magnetic resonance imaging (MRI) outcomes after arthroscopic dynamic anterior stabilization using the long head of the biceps tendon (DAS-LHB) in patients with recurrent anterior glenohumeral instability. The main questions it aims to answer are: * How much does the Western Ontario Shoulder Instability Index (WOSI) change from before surgery to a minimum of 2 years after DAS-LHB? * What is the structural integrity and healing status of the transferred long head of the biceps tendon on routine postoperative MRI obtained at least 6 months after surgery? * What are the postoperative rates of recurrent instability, reoperation, residual apprehension, return to sport, and changes in shoulder function and range of motion? Researchers will also compare patients who underwent isolated DAS-LHB with patients who underwent DAS-LHB combined with Hill-Sachs remplissage to explore whether the addition of remplissage is associated with differences in clinical, functional, and imaging outcomes. This comparison is exploratory and was not randomized. Participants underwent surgery as part of routine clinical care and will not receive any additional treatment or imaging for research purposes. Researchers will review existing clinical records and imaging studies. If routine follow-up data are incomplete, some participants may be contacted by telephone, secure electronic questionnaire, or clinical review to complete standardized outcome assessment.

Eligibility Criteria

Inclusion Criteria: * Age 15 years or older at the time of surgery Arthroscopic dynamic anterior stabilization using the long head of the biceps tendon (DAS-LHB) performed for recurrent anterior glenohumeral instability Index surgery performed between June 2018 and December 2026 At least 24 months elapsed since the index surgery at the time of clinical outcome assessment For MRI-based analyses: availability of a routine postoperative shoulder MRI obtained at least 6 months after the index procedure Exclusion Criteria: * Multidirectional instability or posterior-dominant instability as the primary indication for surgery Prior bone-block procedure on the index shoulder Concomitant rotator cuff repair Concomitant fracture fixation Neurologic injury affecting the operated upper limb Insufficient clinical documentation to establish the primary outcome For MRI-based analyses only: non-diagnostic postoperative MRI For MRI-based analyses only: postoperative MRI not performed because of a clinical contraindication or patient non-attendance

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Source: ClinicalTrials.gov (NCT07892729). StuddyBuddy aggregates publicly available trial information.