Carbon‑fiber lateral plate versus plate-and-nail repair for distal femur fractures
Official title: Identifying Non-Union Rates Using Carbo-fix Lateral Plate Devices and Standard Plate-Nail Construct in Distal Femur Fractures
Run by University of Missouri-Columbia · NCT07280169 · Data updated 2026-11-12
This trial will see if a carbon-fiber (CarboFix) lateral femur plate leads to fewer non-unions than the standard plate-plus-nail repair in adults having surgery for a distal femur fracture.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Status | Recruiting |
| Started | January 29, 2026 |
| Main results expected | December 1, 2028 |
| Study ends | December 1, 2029 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07280169 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older with a distal femur fracture who can give informed consent and complete patient-reported outcome measures are the intended participants.
✕Probably not a fit
Those under 18, currently pregnant or breastfeeding, unable to consent, incarcerated, or with severe cognitive impairment are excluded and would not receive potential benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial will assign adults with distal femur fractures to receive either a CarboFix carbon‑fiber lateral plate or a standard plate-plus-intramedullary-nail construct at a single academic center. Investigators will collect surgical and radiographic data, track union rates over time, and record re-operations and patient-reported outcomes. All procedures are standard-of-care implants and techniques currently used for distal femur fixation. The primary focus is on whether the carbon‑fiber plate reduces non-union and downstream reoperation compared with the combined plate-nail approach.
Why it matters
Potential benefit: If successful, the CarboFix plate could lower non-union and reoperation rates and improve recovery after distal femur fracture surgery.
How similar studies have gone: Prior comparisons have found lower non-union rates with plate-plus-nail constructs versus single lateral plates, while carbon‑fiber fixation is a newer approach with limited published long-term outcome data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients, 18 years or older, with a distal femur fracture requiring surgery * Adult patients able to understand and sign the consent and answer PROs Exclusion Criteria: * Age under 18 years * Currently pregnant or breastfeeding (patient will simply be asked pregnancy status) * Unable to give consent * Prisoner * Mentally disabled
Where it's running
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University of Missouri-Columbia
Columbia, Missouri, United States Recruiting
Study contacts
- Principal investigator: Kyle M Schweser, MD — University of Missouri-Columbia
- Study coordinator: Vicki L Jones, MEd
- Email: jonesvicki@health.missouri.edu
- Phone: 573-882-7583
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.