NCT03643926 Arthroscopic Versus Open Brostrom for Ankle Instability
| NCT ID | NCT03643926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of São Paulo |
| Condition | Ankle Sprains |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2019-06-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 98 participants in total. It began in 2019-06-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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;
Contact & Investigator
Marcel JS Tamaoki, PhD
STUDY CHAIR
Federal University Sao Paulo
Frequently Asked Questions
Who can join the NCT03643926 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Ankle Sprains. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03643926 currently recruiting?
Yes, NCT03643926 is actively recruiting participants. Contact the research team at nacime@nacime.com.br for enrollment information.
Where is the NCT03643926 trial being conducted?
This trial is being conducted at Belo Horizonte, Brazil, São Paulo, Brazil.
Who is sponsoring the NCT03643926 clinical trial?
NCT03643926 is sponsored by Federal University of São Paulo. The principal investigator is Marcel JS Tamaoki, PhD at Federal University Sao Paulo. The trial plans to enroll 98 participants.