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

Disqualifiers: Under 18, Pregnant, Prisoner, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day (surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best treatment for repairing broken thigh bones (distal femur fractures) by comparing two methods. One group will receive a Carbo-fix lateral plate (a type of surgical implant), while the other will receive a standard combination of a plate and a nail. Researchers aim to determine which method results in fewer cases of improper bone healing, leading to fewer follow-up surgeries and better recovery. This trial is suitable for adults who require surgery for a distal femur fracture and can understand and consent to participate. As an unphased trial, it offers patients the opportunity to contribute to important research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these devices are safe for distal femur fracture fixation?

Research shows that the Carbo-fix Lateral Plate Device is generally safe for fixing broken bones. Studies on carbon-fiber plates, such as the Carbo-fix plate, have found they rarely cause problems for patients. One study found these plates work well in the short term for fixing breaks in the lower part of the thigh bone.

For the Standard Plate-Nail Construct, research indicates this method is effective, but some risks exist. Specifically, one study found that about 12% of cases experienced delayed healing, while around 6% had bones that didn't heal or healed incorrectly. Despite these issues, patients usually recover well after the procedure.

Both treatments are part of standard care, meaning doctors already use them to treat patients. This suggests they are considered safe and effective options. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Carbo-fix Lateral Plate Device is unique because it utilizes carbon fiber technology, which is lightweight yet incredibly strong compared to traditional metal implants used in distal femur fractures. Unlike metal plates that can interfere with imaging techniques such as MRIs, carbon fiber is radiolucent, allowing for better post-operative imaging and monitoring. Researchers are excited about the potential for faster recovery times and reduced implant-related complications due to its biocompatibility and flexibility, which can improve patient outcomes significantly over standard metal constructs.

What evidence suggests that this trial's treatments could be effective for distal femur fractures?

This trial will compare the Carbo-fix lateral plate device with the Standard Plate-Nail Construct for treating distal femur fractures. Research has shown that the Carbo-fix lateral plate device effectively treats fractures in the lower thigh bone. Studies indicate that carbon-fiber plates, like Carbo-fix, have lower rates of improper bone healing, leading to better bone recovery and reducing the need for additional surgeries. Early results suggest that Carbo-fix plates perform well and offer healing outcomes similar to standard treatments. Overall, this can lead to a smoother recovery and less inconvenience for patients. ^{1 2 3 4 6}

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo surgery with either the Carbo-fix lateral plate or the standard plate-nail construct

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for union and patient-reported outcomes at regular intervals

1 year

Visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07280169?aggFilters=status%3A

Carbo-fix Lateral Plate Devices and Standard Plate-Nail ...

This study will be collecting data on the standard plate and nail combination and compare outcomes with the Carbofix plate to see differences in ...

2.

trial.medpath.com

trial.medpath.com/clinical-trial/b085c4a88a07c028/nct07280169-non-union-rates-carbo-fix-plate-nail-distal-femur-fractures

Carbo-fix Lateral Plate Devices and Standard Plate-Nail ...

The purpose of this randomized clinical trial is to decrease non-union rates in distal femur fracture fixation. Carbo-fix lateral femur ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10421838/

Carbon-fibre plates for traumatic and (impending ...

Carbon-fibre (CF) plates are increasingly used for fracture fixation. This systematic review evaluated complications associated with CF plate fixation.

4.

invibio.com

invibio.com/en/downloads/trauma/clinical-study-carbofix-locking-plates-in-the-fixation-of-distal-femur-fractures

My Experience with CarboFIX Locking Plates in the ...

My Experience with CarboFIX Locking Plates in the Fixation of Distal Femur Fractures. Alex Jahangir, MD, MMHC presents his experiences of CFR-PEEK at The ...

5.

researchgate.net

researchgate.net/publication/325231973_Early_Comparative_Outcomes_of_Carbon_Fiber_Reinforced_Polymer_Plate_in_the_Fixation_of_Distal_Femur_Fractures

Early Comparative Outcomes of Carbon Fiber Reinforced ...

Conclusion: CFR-PEEK plates show encouraging short-term results in the treatment of distal femur fractures with a comparable nonunion, ...

6.

nature.com

nature.com/articles/s41598-022-23519-9

Complications of patients with bone tumors treated ...

This study suggests CF plates are safe to use in demanding reconstructions after bone tumor resections, presenting a seemingly low complication profile.