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Carbon Fiber Implants

NCT03382041 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-07-25

Study results available
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Summary

The investigators will compare intramedullary nailing of open and closed tibia shaft fractures with carbon fiber implant versus titanium implant in a Level I trauma setting.

Conditions

  • Tibial Shaft Fractures

Interventions

DEVICE

Carbon Fiber Implant

A cannulated rod, made of long carbon fiber reinforced polymer, with interlocking holes at its proximal and distal ends. The Nail provides for a slight bend. A Tantalum radiopaque marker along the Nail longitudinal axis provides for its visualization under fluoroscopy. The Nail proximal end is marked by a tantalum marker.

DEVICE

Titanium Implant

An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body

Sponsors & Collaborators

  • CarboFix Orthopedics

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Clay A Spitler, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2020-03-31
Completion
2021-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03382041 on ClinicalTrials.gov