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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT02128256
Eligibility Criteria:
Inclusion Criteria:
* Patients with a long bone infection in femur, tibia, humerus or radius
* Candidate for one stage procedure
* Patients above the age of 18
* Written informed consent obtained before any study-related activities
* Patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program
Exclusion Criteria:
* Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
* Hypersensitivity to aminoglycoside antibiotics
* Myasthenia gravis
* Severe renal impairment
* Pre existing calcium metabolism disorder.
* Women who are pregnant or breastfeeding (a pregnancy test will be done in women of childbearing potential)
* History of hypersensitivity to the investigational device or any of its ingredients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02128256
Study Brief:
Protocol Section:
NCT02128256