RECRUITING

Intramedullary Bone Grafting for Open Tibial Shaft Fractures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-03-26
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03891888

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient age 18 or older
  2. * Patient with a Gustillo I, II, or IIIa open tibia shaft fracture to be treated primarily with an intramedullary nail
  3. * Primary closure of the open fracture wound during the initial operation
  4. * Consent to participate in the study.
  5. * 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.
  1. * Patients under the age of 18.
  2. * Patients who are pregnant
  3. * Patients with segmental tibia fractures or those with loss of bone
  4. * Patients with skin defects over the tibia that cannot be closed primarily
  5. * Patients with a pathologic fracture of the tibia
  6. * Patient has quadriplegia or paraplegia

Contacts and Locations

Study Contact

Rodolfo Zamora, MD
CONTACT
502-629-5460
razamo02@louisville.edu
Salwa M Rashid, MD, MPH
CONTACT
5028526964
sfrash01@louisville.edu

Principal Investigator

Rodolfo Zamora, MD
PRINCIPAL_INVESTIGATOR
University of Louisville

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Louisville

  • Rodolfo Zamora, MD, PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-26
Study Completion Date2025-02

Study Record Updates

Study Start Date2020-03-26
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • Tibial diaphyseal fracture
  • Nonunion
  • Delayed union

Additional Relevant MeSH Terms

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