Carbon‑fiber lateral plate versus plate-and-nail repair for distal femur fractures
Identifying Non-Union Rates Using Carbo-fix Lateral Plate Devices and Standard Plate-Nail Construct in Distal Femur Fractures
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT07280169 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Columbia, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.