Status:
RECRUITING
Arthroscopic Versus Open Brostrom for Ankle Instability
Lead Sponsor:
Federal University of São Paulo
Conditions:
Ankle Sprains
Instability, Joint
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Background: Ankle sprains are among the most prevalent lesions in primary care. A substantial number of these ligament lesions will develop ankle instability and require a surgical procedure. The Bros...
Detailed Description
1. Introduction Ankle sprains are among the most prevalent lesions in the athletic and non-athletic population(1). Accounting to up than 14% of emergency visits and with an estimated year cost of ...
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;
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 5 2027
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03643926
Start Date
June 1 2019
End Date
December 5 2027
Last Update
September 27 2024
Active Locations (2)
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1
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
2
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil, 04022-001