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:
NCT04653051
Eligibility Criteria:
Inclusion Criteria:
* All subjects must have been implanted with one of the DVR Plates according to the approved indications.
Exclusion Criteria:
* Off-label use.
* Cases where there is an active infection.
* Conditions which tend to retard healing such as, blood supply limitations, previous infections, etc.
* Insufficient quantity or quality of bone to permit stabilization of the fracture.
* Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process.
* Foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantations.
* Cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients.
* Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04653051
Study Brief:
Protocol Section:
NCT04653051