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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00823251
Eligibility Criteria:
Inclusion Criteria:
* Skeletally mature
* Patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure
* Female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours
* Acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation
* Fracture has occurred within past 3 weeks
* Fracture types: transverse, short oblique, or any fracture pattern in which the comminuted segment is equal to or less than the diameter of the bone at fracture site
Exclusion Criteria:
* Patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study
* Patient has experienced a crush, mangling, or burn type injury
* Patient has probable history of infection or confirmed infection at baseline
* Patient has previous diagnosis of a significant bone disorder that may impair bone healing
* Patient has a life expectancy of \< 26 weeks
* Pathological fracture secondary to tumor
* Open fracture of Gustilo-Anderson Type II or III
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00823251
Study Brief:
Protocol Section:
NCT00823251