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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Page 1 of 1 (2 locations)

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