Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT01729195
Eligibility Criteria:
Inclusion Criteria:
* acute, closed Weber C-type ankle fracture
* adult patients (age 18-70 years)
* female subjects of child-bearing potential must have a negative pregnancy test and an approved contraception for the study duration
Exclusion Criteria:
* a previous fracture or infection of the injured ankle or the ipsilateral foot
* significant associated soft-tissue injury
* other long-bone fracture of the lower extremities
* documented active infection at any anatomic site
* a known metabolic skeletal disease (osteoporosis or osteomalasia) or a medication affecting bone structure (such as corticosteroid treatment)
* a pathological fracture
* any underlying systemic disease (such as unbalanced diabetes mellitus or rheumatoid disease) or a condition (such as alcoholism or drug abuse) which are known to affect resistance to infection
* history of prosthetic knee or hip replacement
* pregnant women or nursing mothers
* hypersensitivity to fluoroquinolones or related antibiotics (nalidixine acid)
* any other condition that in the judgment of the investigator would prohibit the subject from participating in the study or may hinder the collection of data and interpretation of the results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01729195
Study Brief:
Protocol Section:
NCT01729195