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

ConditionAnkle Sprain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Francisco de Vitoria

About this trial

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.

Secondary Objectives:

To determine if there are differences in health outcomes and patient-perceived pain using the specific SP-36 scale and verbal numeric rating scale (VNRS). Additionally, to assess differences in postoperative complication rates and time to return to daily life activities between the two surgical techniques.

Study Design:

Prospective, randomized, controlled clinical trial with two parallel groups stratified by age and functional demand.

Condition or Disorder Being Studied:

Chronic lateral ankle instability.

Study Population and Sample Size:

The target population includes subjects diagnosed with chronic lateral ankle instability. The study population consists of patients diagnosed in the Orthopedics consultations at Hospital Infanta Elena who meet the inclusion and exclusion criteria. Based on sample size calculations, a total of 36 patients will be recruited. However, due to the prospective nature and stratification by epidemiological and functional variables, the sample size may be increased to ensure comparable groups in each stratum.

Study Timeline and Estimated Completion Date:

The study is expected to begin in the third quarter of 2025. Recruitment is estimated to last 24 months, with a follow-up period of 12 months, for a total duration of 3 years, ending in the third quarter of 2028.

Eligibility criteria

Qualifiers

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)

Disqualifiers

History of previous ankle surgery

Tibiotalar osteoarthritis or presence of chondral lesions on magnetic resonance imaging

Active infections

Contraindications for surgery

Trial design

Treatments tested in this trial

  • Arthroscopic reconstruction surgery
  • Open surgery

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universidad Francisco de Vitoria

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Sponsor institution

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborator