Actively Recruiting
Arthroscopic Versus Open Brostrom for Ankle Instability
Led by Federal University of São Paulo · Updated on 2024-09-27
98
Participants Needed
2
Research Sites
444 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Arthroscopic Versus Open Brostrom for Ankle Instability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals must be older than 18 and younger than 65 years of age, both genders
- Participants must have experienced ankle instability symptoms for the last six months
- Clinical diagnosis of ankle instability with at least one previous ankle sprain and a positive anterior drawer test confirmed by MRI showing lateral ligament injury
You will not qualify if you...
- Previous surgery involving the affected foot or ankle
- History or evidence of autoimmune or peripheral vascular diseases
- History or evidence of peripheral neuropathy or systemic inflammatory diseases such as rheumatoid arthritis, spondylitis, or Reiter Syndrome
- Associated injuries like osteochondral lesions, tendon ruptures, or fractures
- Associated instability such as syndesmotic or medial instability
- Cavovarus foot deformity
- BMI over 35
- Ankle infiltration within six months before initial assessment
- Pregnancy
- Any condition contraindicating the proposed therapies
- Inability to sign the informed consent form
- History or evidence of blood coagulation disorders (excluding aspirin)
- Use of a heart pacemaker
- Presence of infection in the treatment area, either superficial or deep
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Not Yet Recruiting
2
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil, 04022-001
Actively Recruiting
Research Team
N
Nacime SB Mansur, MD
CONTACT
D
Daniel S Baumfeld, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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