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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT04076735
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients
* 65 years and older
* Isolated fracture of the distal femur (Classification 33)
* Fracture is amendable to both treatments
* Fracture is acute (within 2 weeks from time of injury)
* Patient was ambulatory (with or without walking aids) prior to the injury
* Independent or moderately frail with score of 3 to 6 on the Clinical Frailty Scale
* Patient is able to read and understand English, French, or Spanish
* Patient or substitute decision maker is able to provide written informed consent to participate in the study
Exclusion Criteria:
* Active or previous infection around the fracture (soft tissue or bone)
* Open fracture
* Bilateral femur fractures
* Major vascular injuries requiring intervention, compartment syndrome and major neurologic injuries
* Pathological fracture excluding osteoporosis
* Previous surgical fixation or total knee replacement of the distal femur or proximal tibia
* Previous surgical fixation or hemi/total replacement of the hip
* Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair
* Polytrauma (Injury Severity Score \> 15) or any associated major injuries of the lower extremities
* Previous medical diagnosis of dementia
* Medical or surgical contra-indication to surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04076735
Study Brief:
Protocol Section:
NCT04076735