Comparing two surgical techniques for ankle instability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of the arthroscopic Brostrom technique versus the traditional open Brostrom procedure for treating chronic ankle instability. It will involve 98 patients aged 18 to 65 who have experienced instability symptoms for at least six months. Participants will be randomly assigned to one of the two surgical approaches, and outcomes will be assessed to determine which method provides better pain relief and functional improvement. The study is designed as a blinded, multicentric, randomized trial to ensure robust results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals must be older than 18 and younger than 65 years of age, both genders;
* Participants must be experiencing instability symptoms at the ankle over the last six months;
* Clinical diagnosis of ankle instability, defined as the presence of at least one previous ankle sprain associated with a current instability sensation by the patient and the presence of a positive anterior drawer test; the previous lateral ligament injury must be confirmed by Magnetic Resonance Imaging (MRI) findings.

Exclusion Criteria:

* Previous surgery involving the affected foot or ankle;
* History or documented evidence of autoimmune or peripheral vascular diseases;
* History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, spondylitis, Reiter Syndrome, etc.);
* Associated injuries, such as osteochondral lesions, tendon ruptures and fractures.
* Associated instability, such as syndesmotic and medial instability.
* Cavovarus foot;
* BMI over 35;
* Previous infiltration in the ankle over the six months preceding the initial assessment;
* Pregnancy;
* Any condition that represents a contraindication of the proposed therapies;
* Impossibility or incapacity to sign the informed Consent Form;
* History or documented evidence of blood coagulation disorders (including treatment with anti-coagulants, but excluding aspirin);
* Use of heart pacemaker;
* Presence of infectious process (superficial on skin and cellular tissue, or deep in the bone) in the region to be treated;

Where it's running

• Federal University of Sao Paulo
  São Paulo, São Paulo, Brazil Recruiting
• Federal University of Minas Gerais
  Belo Horizonte, Minas Gerais, Brazil Not yet recruiting

Study contacts

• Study coordinator: Nacime SB Mansur, MD
• Email: nacime@nacime.com.br
• Phone: +5511994500853

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Hip muscle strengthening for chronic ankle instability in athletes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.