Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07200271

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.

Led by Universidad Francisco de Vitoria · Updated on 2025-10-01

36

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

Universidad Francisco de Vitoria

Lead Sponsor

I

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to determine whether arthroscopic reconstruction with allograft offers real benefits compared to the modified open Broström-Gould technique for treating chronic lateral ankle instability. The study will use the clinical AOFAS scale to measure effectiveness and safety, and also assess health outcomes, patient pain levels, complication rates, and recovery time. It is a prospective, randomized, controlled clinical trial with two parallel groups, stratified by age and activity level. The trial compares two surgical methods: one group will receive the modified Broström-Gould open surgery, which rebuilds damaged ligaments using the patient's own tissue through an incision on the fibula's side, while the other group will undergo arthroscopic reconstruction using tendon allografts from tissue banks, performed through small incisions with arthroscopy. Both techniques are being evaluated for their outcomes and safety. Participants diagnosed with chronic lateral ankle instability will be followed for 12 months after surgery, with evaluations including clinical scales, pain assessments, and monitoring for complications. The total study period includes recruitment over 24 months and follow-up for a year, aiming to assess differences in recovery and return to normal activities. The study is led by Universidad Francisco de Vitoria and is expected to complete by 2028.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Subjective sensation of ankle instability
  • Pathological anterior drawer and varus tilt compared to the opposite ankle
  • MRI showing lesion of the anterior talofibular ligament (ATFL)
  • At least one of the following: BMI over 30, high athletic demand in pivoting sports, ligamentous hyperlaxity (Beighton score over 8), first sprain more than 2 years ago, more than 5 sprains per year, subfibular ossicle larger than 1 cm, MRI with high T2 signal in ATFL, or MRI showing disruption or absence of ATFL
Not Eligible

You will not qualify if you...

  • Previous ankle surgery
  • Tibiotalar osteoarthritis or chondral lesions seen on MRI
  • Active infections
  • Contraindications for surgery
  • Pregnancy
  • Lactation
  • Known allergy to bovine collagen
  • Autoimmune connective tissue disease
  • Active cancer process

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and hospital stay as required

Participants undergo either the modified Broström-Gould open surgery or arthroscopic reconstruction with allograft to repair ankle ligaments, followed by immediate post-operative care.

1 surgical visit plus immediate post-operative assessments

Post-operative Follow-up

Duration - Up to 12 months after surgery

Participants are monitored for recovery, complications, pain, and functional outcomes after surgery.

Approximately 6 post-operative visits

Trial Site Locations

Total: 1 location

1

Hospital Universitario Infanta Elena

Valdemoro, Madrid, Spain, 28342

Actively Recruiting

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Research Team

J

Juan Chans Veres, Md, PhD

L

Laura Conde Ruiz, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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