Geriatric Distal Femur
NCT07237191 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256
Last updated 2026-03-06
Summary
The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.
Conditions
- Articular Fractures
Interventions
- PROCEDURE
-
Single Implant Fixation
Lateral precontoured 4.5 mm distal femur plate or an intramedullary nail at the surgeon's discretion. Standard-of-care techniques will be used by the surgeon for fracture reduction and implant placement.
- PROCEDURE
-
Dual Implant Fixation
Lateral precontoured distal femur plate and either (1) an intramedullary nail or (2) a medial plate. The medial plate must span the extra-articular portion of the fracture and must have stiffness of a 3.5 mm reconstruction plate, 3.5 mm limited contact dynamic compression plate, or greater.
Sponsors & Collaborators
-
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Laurence Kempton, M.D. · Wake Forest University Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
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