RECRUITING

Intramedullary Bone Grafting for Open Tibial Shaft Fractures

Description

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.

Study Overview

Study Details

Study overview

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.

Open Tibial Shaft Fractures: Can Packing the Exposed Cortex With Intramedullary Reamings Increase Union Rates

Intramedullary Bone Grafting for Open Tibial Shaft Fractures

Condition
Tibial Fractures
Intervention / Treatment

-

Contacts and Locations

Louisville

University of Louisville Hospital, Louisville, Kentucky, United States, 40202

Louisville

University of Louisville Hospital, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient age 18 or older
  • * Patient with a Gustillo I, II, or IIIa open tibia shaft fracture to be treated primarily with an intramedullary nail
  • * Primary closure of the open fracture wound during the initial operation
  • * Consent to participate in the study.
  • * Are able and willing to return to the hospital or clinic for follow-up for a period of 6-9 months or until radiographic union.
  • * Patients under the age of 18.
  • * Patients who are pregnant
  • * Patients with segmental tibia fractures or those with loss of bone
  • * Patients with skin defects over the tibia that cannot be closed primarily
  • * Patients with a pathologic fracture of the tibia
  • * Patient has quadriplegia or paraplegia

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Louisville,

Rodolfo Zamora, MD, PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

2025-02