Comparing modified Broström-Gould open repair versus arthroscopic allograft reconstruction for chronic lateral ankle instability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, controlled trial that will assign adults with chronic lateral ankle instability to either arthroscopic allograft reconstruction of the anterior talofibular and calcaneofibular ligaments or to a modified open Broström-Gould repair. Treatment groups are stratified by age and functional demand and the primary outcome is the AOFAS clinical scale. Secondary outcomes include health-related quality of life (SP-36), pain measured by a verbal numeric rating scale (VNRS), postoperative complication rates, and time to return to daily activities. Patients must meet clinical and MRI criteria for ATFL injury and will be treated and followed at Hospital Universitario Infanta Elena in Valdemoro, Madrid.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Universitario Infanta Elena
  Valdemoro, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Juan Chans Veres, MD-PhD — Hospital Universitario Infanta Elena
• Study coordinator: Juan Chans Veres, Md, PhD
• Email: juan.chans@quironsalud.es
• Phone: +34 678133294

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.