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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02456194
Eligibility Criteria:
Inclusion Criteria:
* Adult (skeletally mature) men or women;
* Acute, closed, tibial plateau fractures, Schatzker grade 1 through 5;
* Internal fixation and use of study device per protocol;
* Fracture repair within 30 days of injury;
* Signed informed consent to participate in study.
Exclusion Criteria:
* Uncontrolled diabetes;
* Severe degenerative or metabolic bone disease;
* Malignancy;
* Severe vascular or neurologic disease;
* Alcoholism;
* Substance abuse;
* Use of systemic steroids;
* Immunosuppressive therapy;
* Hypercalcaemia;
* Renal-compromised patients;
* Osteomyelitis or chronic infection in the study limb;
* Women who are pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02456194
Study Brief:
Protocol Section:
NCT02456194