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NCT Number: NCT07200271

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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

    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.

Secondary outcomes

  1. Determine whether there are differences in health outcomes

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

    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).

  2. Determine whether there are differences in patient-perceived pain

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

    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).

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

    Time frame: 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, 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.

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Chans Veres, Md, PhD

CONTACT

[email protected]

+34 678133294

Laura Conde Ruiz, MD

CONTACT

[email protected]

+34 695155570

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Collaborators

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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