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Ankle surgery showdown: new minimally invasive technique vs. gold standard

NCT ID NCT07200271

Disease control Sponsor: Universidad Francisco de Vitoria Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two surgical approaches for chronic ankle instability: a newer arthroscopic technique using donor tissue (allograft) versus the standard open Broström-Gould repair using the patient's own tissue. Researchers will enroll 36 adults with chronic ankle sprains and follow them for one year after surgery to see which method provides better pain relief, function, and safety. The goal is to determine if the newer technique offers real advantages or if both are equally effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgical procedure (arthroscopic allograft reconstruction or open Broström-Gould repair)
What this could lead to
If one technique proves better, it could lead to improved recovery and fewer complications for people with chronic ankle instability.
What could go wrong
This is a small, early-stage trial with only 36 patients, so results may not apply to everyone. Both surgeries carry standard surgical risks like infection or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ankle injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankle sprain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario Infanta Elena

    RECRUITING

    Valdemoro, Madrid, 28342, Spain

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