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

NCT ID: NCT07200271

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-09-01

Brief Summary

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.

Conditions

Ankle Sprain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Open surgery

Intervention Type: PROCEDURE

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. This technique has shown satisfactory functional results.

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

Group Type: ACTIVE_COMPARATOR

Arthroscopic reconstruction surgery

Intervention Type: PROCEDURE

Arthroscopic reconstruction with allograft, in which a tendon (generally from a tissue bank) is used to reconstruct the ligaments. This technique is performed through small incisions using arthroscopy.

Interventions

Arthroscopic reconstruction surgery

Arthroscopic reconstruction with allograft, in which a tendon (generally from a tissue bank) is used to reconstruct the ligaments. This technique is performed through small incisions using arthroscopy.

Intervention Type: PROCEDURE

Open surgery

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. This technique has shown satisfactory functional results.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role: collaborator

Universidad Francisco de Vitoria

OTHER

Sponsor Role: lead

Responsible Party

Juan Chans Veres

Attending Physician, Foot and Ankle Unit, Department of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Chans Veres, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Infanta Elena

Locations

Hospital Universitario Infanta Elena

Valdemoro, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Juan Chans Veres, Md, PhD

Role: CONTACT

juan.chans@quironsalud.es

+34 678133294

Laura Conde Ruiz, MD

Role: CONTACT

laura.conde@quironsalud.es

+34 695155570

Facility Contacts

Laura Conde Ruiz, MD

Role: primary

laura.conde@quironsalud.es

+34 695155570

Juan Chans Veres, MD-PhD

Role: backup

juan.chans@quironsalud.es

678133294

Other Identifiers

INEST2025

Identifier Type: -

Identifier Source: org_study_id