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Compares treatment options for Ankle Sprains
Official title Arthroscopic Versus Open Brostrom for Ankle Instability
ClinicalTrials.gov ID: NCT03643926
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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...
- Associated injuries, such as osteochondral lesions, tendon ruptures and fractures.
- Associated instability, such as syndesmotic and medial instability.
- Cavovarus foot;
See the full eligibility 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Belo Horizonte, Minas Gerais, Brazil
- São Paulo, São Paulo, Brazil
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belo Horizonte, Minas Gerais, Brazil; São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.