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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Sprain
• Intervention / Treatment: Procedure: Open surgery; Procedure: Arthroscopic reconstruction surgery

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Chans Veres, Md, PhD; Phone Number: +34 678133294; Email: juan.chans@quironsalud.es
• Study Contact Backup: Name: Laura Conde Ruiz, MD; Phone Number: +34 695155570; Email: laura.conde@quironsalud.es

Study Locations

• Spain
  • Madrid
    • Valdemoro, Madrid, Spain, 28342
      • Recruiting
      • Hospital Universitario Infanta Elena
      • Contact: Laura Conde Ruiz, MD; Phone Number: +34 695155570; Email: laura.conde@quironsalud.es
      • Contact: Juan Chans Veres, MD-PhD; Phone Number: 678133294; Email: juan.chans@quironsalud.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether there are differences in health outcomes	Determine whether there are differences in health outcomes using the specific SP-36 (Short Form Health Survey) scale, is a 36-item questionnaire designed to measure health-related quality of life, it measures eight items: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health. The score goes from 0 (worst health status) to 100 (best health status).	From surgery to the end of the follow up at 12 months after surgery
Determine whether there are differences in patient-perceived pain	Determine whether there are differences in patient-perceived pain by using verbal numerical rating scale (VNRS). This score is widely used tool for assessing pain intensity, it measures pain from 0 (no pain) to 10 (worst paing imaginable).	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.	Determine whether there are differences between both groups in the rate of postoperative complications, defined as: Delay or absence of surgical wound healing, superficial infection, deep infection, recurrence or persistence of instability, sural nerve and superficial peroneal nerve neuropathy and complex regional pain syndrome. They are all qualitative variables. They will be expressed in the categories: yes or no.	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.	Determine whether there are differences in the time to return to normal life between the two surgical techniques. To do this, we will compare both groups in terms of time expressed in days.	From surgery to the end of the follow up at 12 months after surgery

Collaborators and Investigators

• Sponsor: Universidad Francisco de Vitoria
• Collaborators: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Investigators: Principal Investigator: Juan Chans Veres, MD-PhD, Hospital Universitario Infanta Elena

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: September 26, 2025
• First Posted (Estimated): October 1, 2025

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: ALLOGRAFT; INSTABILITY; ANKLE; LIGAMENT
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Endoscopy; Conversion to Open Surgery
• Other Study ID Numbers: INEST2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No