RecruitingNot ApplicableNCT03643926

Arthroscopic Versus Open Brostrom for Ankle Instability

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

Sponsor

Federal University of São Paulo

Enrollment

98 participants

Start Date

Jun 1, 2019

Study Type

INTERVENTIONAL

Conditions

ankle sprains Surgery Ligament Injury Instability, Joint

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 Brostrom-Gould technique is the standard surgical approach for this condition, providing excellent results over the years. Thru the last decades, the arthroscopic Brostrom has gain popularity and support by several studies. Yet, there is no consensus regarding the best procedure to treat ankle instability nowadays. Hypothesis: The arthroscopic Brostrom technique will present better levels of pain and function when compared to the standard open approach. Design: blinded, in parallel groups, multicentric, randomized, clinical trial. Materials and Methods: 98 patients with a diagnosis of chronic ankle instability, referred from primary or secondary health care services, will be assessed and enrolled in this study. Participants will be divided in two groups (randomized by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the open Brostrom repair technique and the other comprehending the arthroscopic Brostrom approach. The assessments will occur in 3, 6, 12, 24 and 48 weeks. Patients will be evaluated primarily by complications and secondarily the Cumberland Ankle Instability Tool (CAIT), American Orthopedic Foot and Ankle Society (AOFAS), the Visual Analogue Scale (VAS), the Foot Function Index (FFI) and the 36 Item Short Form Health Survey (SF-36). The investigators will use Comparison of Two Proportions via relative frequency analysis, the Pearson Correlation the Chi-Square test and the ANOVA for statistical analyses. Discussion: This study intends to establish if the arthroscopic Brostrom technique can produce excellent and reliable results when treating chronic ankle instability. A shorter surgical time, a better cosmetic appearance and a smaller soft tissue injury would support the choice for this procedure if the outcomes could be compared to the open approach.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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 Criteria14

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;