What this study is
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.
What's being tested
- Single Implant Fixation
Intervention · PROCEDURE
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.
- Dual Implant Fixation
Intervention · PROCEDURE
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.
Study details
- Official title
- Single Impact Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures in Geriatric Patients
- Sponsor
- Wake Forest University Health Sciences
- Conditions
- Articular Fractures
- Enrolling
- 256 people
- Starts
- 2026-08-23
- Est. completion
- 2029-12
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age greater than or equal to 55 years
- Surgically treated displaced distal femur extra articular or complete articular fractures
You can't join if
- Patients with injury features that preclude treatment with 2 implants
- Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
- Body Mass Index (BMI) > 40
- Injury due to ground level fall
- Patient that speaks neither English or Spanish
- Patients with multisystem injuries that could preclude return to work
- < 55 years of age
- Prisoner
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openAtrium Health
Charlotte, North Carolina, United States
Recruiting
Study team
Sponsor
Wake Forest University Health Sciences
Study ID IRB00139405
Principal investigator
Laurence Kempton, M.D.
Wake Forest University Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.