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