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Compares treatment options for Ankle Sprain
Official title Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments.
ClinicalTrials.gov ID: NCT07200271
What this study is testing
- What it's testing
- 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.
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- History of previous ankle surgery
- Tibiotalar osteoarthritis or presence of chondral lesions on magnetic resonance imaging
- Active infections
- Contraindications for surgery
- Pregnancy
- Lactation
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Valdemoro, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valdemoro, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.