Recruiting

Carbo-fix & Nail-Plate

Sponsor:

University of Missouri-Columbia

Code:

NCT07280169

Conditions

Distal Femur Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carbo-fix Lateral Plate Device

Standard Plate-Nail Construct

Study Details

Brief summary:

The purpose of this randomized clinical trial is to decrease non-union rates in distal femur fracture fixation. Carbo-fix lateral femur plate and standard intramedullary nail-plate constructs have been shown to have lower non-union rates. With decreased non-union rates, re-operation rates will decrease, leading to improved patient outcomes and clinical care. This study will randomize patients to one of the two groups. Then investigators will be collecting data on the standard plate and nail combination and compare outcomes with the Carbofix plate to see differences in union rates. All procedures are currently standard of care and no procedures are research only.

Conditions

Distal Femur Fracture

Study ID

NCT07280169

Start date

Jan 29, 2026

Status verified date

Feb, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Carbo-fix Lateral Plate Device

active comparator: Standard Plate-Nail Construct

Interventions

Carbo-fix Lateral Plate Device

Participants that are randomized to this group will have their distal femur fracture repaired with the Carbofix carbon fiber lateral locking plate

Standard Plate-Nail Construct

Participants who randomize to this group will have their distal femur fracture repaired with the standard lateral plate and intramedullary nail construct.

Primary outcome measure

  • The total number of participants that have non-union of their distal femur fractures when utilizing a carbon fiber lateral plate only or a standard nail/plate combination as assessed by standard of care radiographs. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Vicki L Jones, MEd

573-882-7583jonesvicki@health.missouri.edu

Nash Kolb

573-884-8428kolbn@health.missouri.edu

Locations

University of Missouri-Columbia

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Vicki L Jones, MEd

573-882-7583jonesvicki@health.missouri.edu

Principal Investigator:

Kyle M Schweser, MD

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Distal Femur Fracture
  • Carbofix
  • Plate-Nail Construct

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-02-17.