Arthroscopic Versus Open Brostrom for Ankle Instability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFederal University of São Paulo
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Arthroscopic Brostrom
Procedure/SurgeryBrostrom-Gould lateral ligament ankle reconstruction performed by arthroscopic view
Open Brostrom
Procedure/SurgeryBrostrom-Gould lateral ligament ankle reconstruction performed by an open approach.
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: Arthroscopic BrostromExperimental treatment 1 intervention
Group B: Open BrostromActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Complications (change)
* Dehiscence: inability to heal the soft tissue coverage until the end of the 4th post-operative week. * Peripherical nerve damage: hypoesthesia or paresthesia not solved until the end of the 6th month after the surgery. * Infection: clinical signs of site infection or pus drainage at the wound that required the use of antibiotics. * Re-rupture: an ankle sprain event during the follow-up.
Time frame
3, 6, 12, 24 and 48 weeksSecondary outcomes
1
Cumberland Ankle Instability Tool - CAIT (change)
Ankle Instability Measurement (0 to 30; higher = better)
Time frame
3, 6, 12, 24 and 48 weeks2
American Orthopedic Foot and Ankle Society - AOFAS (change)
AOFAS Hindfoot Scale for Function (0 to 100; higher = better)
Time frame
3, 6, 12, 24 and 48 weeks3
Visual Analogue Scale - VAS (change)
Pain assessment (0 to 10; higher = worse)
Time frame
3, 6, 12, 24 and 48 weeks4
Foot Function Index - FFI (change)
Global Foot Function (0 to 100%; higher = worse)
Time frame
3, 6, 12, 24 and 48 weeksSponsors and contacts
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Source ClinicalTrials.gov