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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT01693367
Eligibility Criteria:
Inclusion Criteria:
* 21 years and older
* Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty
* Ability to walk independently prior to injury
* Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP)
* Willing and able to comply with post-operative protocol and return for follow-up.
* Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation
* Signed informed consent
Exclusion Criteria:
* Additional ipsi- or contralateral lower extremity fracture
* Any kind of implant at the ipsilateral proximal femur
* Pre-existing malunion or nonunion of the ipsilateral lower extremity
* Segmental bone defect requiring bone grafting
* More than 4 weeks between injury and surgery
* Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
* Polytrauma
* Active malignancy
* Any not medically managed severe systemic disease
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the study period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
120 Years
Study:
NCT01693367
Study Brief:
Protocol Section:
NCT01693367