Comparing two surgical techniques for ankle instability

Arthroscopic Versus Open Brostrom for Ankle Instability: a Randomized Clinical Trial

This study is testing whether a new ankle surgery method works better than the traditional one for people with chronic ankle instability.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Federal University of São Paulo (Academic / other)
• Locations: 2 sites (Belo Horizonte, Minas Gerais and 1 other locations)
• Trial ID: NCT03643926 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 to 65 with a clinical diagnosis of chronic ankle instability and a history of at least one previous ankle sprain.

Not a fit: Patients with previous ankle surgeries, autoimmune diseases, or associated injuries like fractures or tendon ruptures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients with chronic ankle instability.

How similar studies have performed: Previous studies have shown promising results for arthroscopic techniques in ankle surgery, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Belo Horizonte, Minas Gerais and 1 other locations

• Federal University of Minas Gerais — Belo Horizonte, Minas Gerais, Brazil (Not_yet_recruiting)
• Federal University of Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Nacime SB Mansur, MD

Conditions Ankle Sprains; Instability, Joint; Ligament Injury; Surgery; ankle; instability; brostrom; open