Status:
RECRUITING
Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments.
Lead Sponsor:
Universidad Francisco de Vitoria
Collaborating Sponsors:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Conditions:
Ankle Sprain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07200271
Start Date
September 1 2025
End Date
September 1 2028
Last Update
October 1 2025
Active Locations (1)
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1
Hospital Universitario Infanta Elena
Valdemoro, Madrid, Spain, 28342