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Intramedullary Bone Grafting for Open Tibial Shaft Fractures

NCT03891888 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-05-22

No results posted yet for this study

Summary

This study will examine if there is a difference between the time to full union between the control group and the study group. Each group will be composed of patients who have an open fracture in the mid tibia. Both groups will undergo primary fixation via reamed intramedulary nailing (IMN), a common treatment for tibia shaft fractures in adults. The study group will have a bone graft applied to the open cortex of the fracture. The bone graft will be composed of the intramedullary reamings, which are a byproduct produced when the intramedullary canal is reamed in preparation for insertion of the IMN.

Conditions

  • Tibial Fractures
  • Nonunion of Fracture
  • Delayed Union of Fracture

Interventions

PROCEDURE

Intramedullary Bone Graft

Patients in this group will undergo standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing), but will also have the reamings from the medullary canal preparation collected and packed into the exposed fracture cortex

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Rodolfo Zamora, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-26
Primary Completion
2025-02-28
Completion
2025-02-28

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 NCT03891888 on ClinicalTrials.gov