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:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01828905
Eligibility Criteria:
Inclusion Criteria:
* patients with traumatic, closed, depression fracture of the proximal tibia (limited to AO type B2 \& B3)
* solitary trauma
* candidate for bone grafting
* patients between the age of 18 and 65 years
* 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:
* patients with multiple injuries
* polytrauma patients
* compartment syndrome
* previous iliac crest bone graft harvesting
* local infection at the site of implantation
* chronic pain disease
* malignancy
* rheumatoid arthritis
* chronic cortisone intake
* X-ray diagnostics not available, fracture cannot be classified
* clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
* a pre-existing calcium metabolism disorder (e.g. hypercalcemia)
* known hyperthyroidism or autonomous thyroid adenoma
* history of serious reaction to iodine based radio contrast agents
* women who are pregnant or breastfeeding
* irreversible coagulopathy or bleeding disorder
* history of physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment complications
* history of hypersensitivity to the investigational device or any of its ingredients
* participation in other clinical trials during the present clinical trial or within the last 1 month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01828905
Study Brief:
Protocol Section:
NCT01828905