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Arthroscopic Versus Open Brostrom for Ankle Instability

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Dec 1, 2023 to Dec 1, 2026
    • Study completion date: Dec 5, 2024 to Dec 5, 2027
    • Site contacts updated at 1 of 2 sites
    v7
  2. Notable Primary completion date: Jul 1, 2021 to Dec 1, 2023
    • Study completion date: Dec 5, 2021 to Dec 5, 2024
    v6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2019 to Jun 1, 2019
    • Site details revised at 2 of 2 sites
    v4
  5. Minor Eligibility criteria expanded, about 5 wordsv3
  6. Notable Start date: Oct 1, 2018 to Mar 1, 2019
    • Study sites: 1 to 2
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03643926
Lead Sponsor Federal University of São Paulo
Conditions
(from sponsor)
Ankle Sprains, Instability, Joint, Ligament Injury, Surgery
Related terms Ankle Injuries, Joint Instability
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov