Comparing modified Broström-Gould open repair versus arthroscopic allograft reconstruction for chronic lateral ankle instability
Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments. A Randomized Stratified Clinical Trial.
This trial will test whether arthroscopic allograft reconstruction or the modified Broström-Gould open repair helps adults with chronic lateral ankle instability have better function and less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Francisco de Vitoria Academic / other |
| Locations | 1 site (Valdemoro, Madrid) |
| Trial ID | NCT07200271 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic chronic lateral ankle instability, pathological anterior drawer/varus tilt and MRI evidence of ATFL lesion, who have not had prior ankle surgery and have no significant tibiotalar osteoarthritis.
Not a fit: Patients with prior ankle surgery, tibiotalar osteoarthritis or chondral lesions, active infection, pregnancy or lactation, autoimmune connective tissue disease, known allergy to bovine collagen, or other contraindications for surgery are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify a surgical option that improves ankle function, reduces pain, or shortens recovery time for people with chronic lateral ankle instability.
How similar studies have performed: Open Broström-Gould repair is a well-established standard with consistently good outcomes, while arthroscopic allograft reconstructions are newer and have shown promising but less extensive evidence so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Valdemoro, Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.