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

NCT07200271 | Recruiting

• 1 other identifier: INEST2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

ALLOGRAFT; INSTABILITY; ANKLE; LIGAMENT

Outcome Measures

Primary Outcomes (1)

• 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.

  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. For this purpose, the clinical AOFAS (American Orthopedics Foot and Ankle Score) score will be used. The minimum value for the AOFAS score is 0 and the maximum value is 100. Higher scores on the AOFAS scale indicate a better outcome, meaning less pain, better function, and improved alignment.

  From surgery to the end of the follow up at 12 months after surgery

Secondary Outcomes (4)

• Determine whether there are differences in health outcomes

  From surgery to the end of the follow up at 12 months after surgery

• Determine whether there are differences in patient-perceived pain

  From surgery to the end of the follow up at 12 months after surgery

• Determine whether there are differences between both groups in the rate of postoperative complications.

  From surgery to the end of the follow up at 12 months after surgery

• Determine whether there are differences in time to return to normal life between the two surgical techniques.

  From surgery to the end of the follow up at 12 months after surgery

Study Arms (2)

Open surgery arm

ACTIVE COMPARATOR

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.

Procedure: Open surgery

Arthroscopic surgery

ACTIVE COMPARATOR

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

Procedure: Arthroscopic reconstruction surgery

Interventions

Arthroscopic reconstruction surgery 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.

Arthroscopic surgery

Open surgery 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.

Open surgery arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead
• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: collaborator

Study Sites (1)

Hospital Universitario Infanta Elena

Valdemoro, Madrid, 28342, Spain

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Juan Chans Veres, MD-PhD

  Hospital Universitario Infanta Elena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Chans Veres, Md, PhD

CONTACT

+34 678133294; juan.chans@quironsalud.es

Laura Conde Ruiz, MD

CONTACT

+34 695155570; laura.conde@quironsalud.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Foot and Ankle Unit, Department of Orthopaedic Surgery

Model Details: This is a randomized clinical trial with two parallel treatment arms, stratified by age and functional demand. One arm will undergo one of the reference surgical interventions for the treatment of chronic lateral ankle instability: the modified open Broström-Gould procedure. The other arm will undergo a more recently developed surgical intervention supported by studies with favorable outcomes: arthroscopic reconstruction of the anterior talofibular ligament and the calcaneofibular ligament.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

ES (1)