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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01429012
Eligibility Criteria:
Inclusion Criteria:
* Male or female; female patients must use a reliable contraception method
* Age ≥ 18 years
* Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction.
* No sepsis
* Good skin covering
* Be able and willing to participate in the study
* Written informed consent
Exclusion Criteria:
* Evidence of malignancy (except non-melanoma skin cancer) in the past five years
* Pregnancy or breastfeeding
* Patient positive by serology or PCR for HIV, hepatitis B or C infection
* Insufficient reduction of the fracture with displaced fragments
* Evidence of local sepsis by clinical signs, biological parameters (CRP) and/or positive isotopic scan using Indium-labelled leucocytes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01429012
Study Brief:
Protocol Section:
NCT01429012