Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractures

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT07280169
Status
Recruiting
Apply to this trial

Conditions

  • Distal Femur Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carbo-fix Lateral Plate Device — 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 — DEVICE
    Participants who randomize to this group will have their distal femur fracture repaired with the standard lateral plate and intramedullary nail construct.

Study Details

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.

Key Dates

Start date
Jan 29, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Carbo-fix Lateral Plate Device
  • Active Comparator: Standard Plate-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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Missouri-ColumbiaColumbiaMissouri65201
Vicki L Jones, MEd
[email protected]
573-882-7583
Kyle M Schweser, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbia, MO

By research site
University of Missouri-Columbia· Columbia, MO

Related Studies