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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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⁃ 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

Locations
Other Locations
Spain
Hospital Universitario Infanta Elena
RECRUITING
Valdemoro
Contact Information
Primary
Juan Chans Veres, Md, PhD
juan.chans@quironsalud.es
+34 678133294
Backup
Laura Conde Ruiz, MD
laura.conde@quironsalud.es
+34 695155570
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 36
Treatments
Active_comparator: Open surgery arm
Open surgery consists of the modified Broström-Gould technique, which allows for the reconstruction of damaged ligaments using the patient's own tissues through an incision on the lateral side of the fibula.
Active_comparator: Arthroscopic surgery
Arthroscopic reconstruction with allograft is a surgery in which a tendon (generally from a tissue bank) is used to reconstruct the ligaments. This technique is performed through small incisions using arthroscopy
Related Therapeutic Areas
Sponsors
Leads: Universidad Francisco de Vitoria
Collaborators: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

This content was sourced from clinicaltrials.gov