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Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments.

RecruitingNAAges 18 Years - anyAllUniversidad Francisco de Vitoria
NCT07200271 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Primary Objective: To clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety. The clinical AOFAS scale will be used for assessment. Secondary Objectives: To determine if there are differences in health outcomes and patient-perceived pain using the specific SP-36 scale and verbal numeric rating scale (VNRS). Additionally, to assess differences in postoperative complication rates and time to return to daily life activities between the two surgical techniques. Study Design: Prospective, randomized, controlled clinical trial with two parallel groups stratified by age and functional demand. Condition or Disorder Being Studied: Chronic lateral ankle instability. Study Population and Sample Size: The target population includes subjects diagnosed with chronic

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📋 Eligibility rules (as published)
Inclusion Criteria: Mandatory criteria (all must be marked "yes" in a drop-down tab): * Age \>18 years * Subjective sensation of instability * Pathological anterior drawer and varus tilt compared to the contralateral side * Magnetic resonance imaging showing lesion of the anterior talofibular ligament (ATFL) Specific criteria (must meet at least one, but can meet several, multiple choice option): * BMI \>30 * High athletic demand (regularly participates in pivoting sports) * Ligamentous hyperlaxity (Beighton score \>8) * First sprain more than 2 years ago * More than 5 sprains per year * Subfibular ossicle \>1 cm * MRI with ATFL showing high T2 signal * MRI showing disruption/absence of ATFL Exclusion Criteria: * History of previous ankle surgery * Tibiotalar osteoarthritis or presence of chondral lesions on magnetic resonance imaging * Active infections * Contraindications for surgery * Pregnancy * Lactation * Known allergy to bovine collagen * Autoimmune connective tissue disease * Active oncological process
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What it tests

  • Arthroscopic reconstruction surgery
  • Open surgery
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Where

1 site
Hospital Universitario Infanta Elena
Valdemoro, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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