Carbo-fix vs Standard Constructs for Distal Femur Fractures

Overseen By Nash Kolb

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Kyle M Schweser, MD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for individuals with a specific type of leg bone fracture at the lower end, known as distal femur fractures. Participants must meet certain health criteria to join, but these specifics are not provided in the given information.

Inclusion Criteria

Adult patients able to understand and sign the consent and answer PROs

I am 18 or older and need surgery for a broken thigh bone near the knee.

Exclusion Criteria

I am unable to understand and give consent for treatment.

I am under 18 years old.

Currently pregnant or breastfeeding (patient will simply be asked pregnancy status)

What Are the Treatments Tested in This Trial?

Interventions

• Carbo-fix Lateral Plate Device
• Standard Plate-Nail Construct

Trial Overview The study is testing two methods of surgical repair for these fractures: one uses a Carbo-fix Lateral Plate Device and the other uses a Standard Plate-Nail Construct. The goal is to see which method leads to fewer cases where bones don't heal properly (non-unions).

How Is the Trial Designed?

Group I: Carbo-fix Lateral Plate Device Active Control 1 Intervention

Group II: Standard Plate-Nail Construct Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

CarboFix Orthopedics Ltd.

Industry Sponsor

Trials

1

Recruited

50+