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

NCT07280169 | Recruiting FDA Device

• 1 other identifier: 2097810
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Distal Femur Fracture; Carbofix; Plate-Nail Construct

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (12)

• The average scores of the patient reported outcomes for pain scores in distal femur fractures with the carbon fiber lateral plate or the nail plate combination as assessed by standard of care with VAS Pain scores.

  1 year

• The average scores of the patient reported outcomes for the PROMIS PF in distal femur fractures with the carbon fiber lateral plate or the nail plate combination as assessed by standard of care patient reported outcome measures.

  1 year

• The average scores of the patient reported outcomes for the PROMIS PI in distal femur fractures with the carbon fiber lateral plate or the nail plate combination as assessed by standard of care patient reported outcome measures.

  1 year

• The total number of patients with infection in the lateral plate versus the nail plate combination cohorts as assessed by standard of care wound check at follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year.

  1 year

• The average time to union (weeks) for the Carbo-fix lateral plate versus nail plate combination as assessed by standard of care radiographs

  1 year

Study Arms (2)

Carbo-fix Lateral Plate Device

ACTIVE COMPARATOR

Device: Carbo-fix Lateral Plate Device

Standard Plate-Nail Construct

ACTIVE COMPARATOR

Device: Standard Plate-Nail Construct

Interventions

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.

Standard Plate-Nail Construct

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

Carbo-fix Lateral Plate Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age under 18 years
• Currently pregnant or breastfeeding (patient will simply be asked pregnancy status)
• Unable to give consent
• Prisoner
• Mentally disabled

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• CarboFix Orthopedics Ltd.: collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65201, United States

RECRUITING

Related Publications (5)

• Utility of Carbon Fiber Implants in Orthopedic Surgery: Literature Review Ronald Hillock, MD, Shain Howard, BS Reconstructive Review v. 4, n. 1 (31 March 2014): 55-55

  BACKGROUND

• Garala K, Ramoutar D, Li J, Syed F, Arastu M, Ward J, Patil S. Distal femoral fractures: A comparison between single lateral plate fixation and a combined femoral nail and plate fixation. Injury. 2022 Feb;53(2):634-639. doi: 10.1016/j.injury.2021.11.011. Epub 2021 Nov 10.

  PMID: 34836629 BACKGROUND

• Rodriguez EK, Boulton C, Weaver MJ, Herder LM, Morgan JH, Chacko AT, Appleton PT, Zurakowski D, Vrahas MS. Predictive factors of distal femoral fracture nonunion after lateral locked plating: a retrospective multicenter case-control study of 283 fractures. Injury. 2014 Mar;45(3):554-9. doi: 10.1016/j.injury.2013.10.042. Epub 2013 Nov 4.

  PMID: 24275357 BACKGROUND

• Ebraheim NA, Martin A, Sochacki KR, Liu J. Nonunion of distal femoral fractures: a systematic review. Orthop Surg. 2013 Feb;5(1):46-50. doi: 10.1111/os.12017.

  PMID: 23420747 BACKGROUND

• Khan AM, Tang QO, Spicer D. The Epidemiology of Adult Distal Femoral Shaft Fractures in a Central London Major Trauma Centre Over Five Years. Open Orthop J. 2017 Nov 13;11:1277-1291. doi: 10.2174/1874325001711011277. eCollection 2017.

  PMID: 29290866 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Kyle M Schweser, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicki L Jones, MEd

CONTACT

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

Nash Kolb

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR OF ORTHOPAEDIC SURGERY

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 12, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)