Recruiting

Bone Grafting

Sponsor:

University of Louisville

Code:

NCT03891888

Conditions

Tibial Fractures

Nonunion of Fracture

Delayed Union of Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intramedullary Bone Graft

Study Details

Brief 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

Study ID

NCT03891888

Start date

Mar 26, 2020

Status verified date

May, 2024

Completion date

Feb, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control

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)

experimental: Intervention

Patients in this group will receive a bone graft in addition to the undergoing standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing)

Interventions

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

Primary outcome measure

  • Radiographic Union at 6 months [ Time Frame: 6 months ]
  • Radiographic Union at 4 months [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Rodolfo Zamora, MD

502-629-5460razamo02@louisville.edu

Salwa M Rashid, MD, MPH

5028526964sfrash01@louisville.edu

Locations

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Rodolfo Zamora, MD

502-629-5460razamo02@louisville.edu

Salwa M Rashid, MD,MPH

5028526964sfrash01@louisville.edu

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Rodolfo Zamora, MD

502-629-5460razamo02@louisville.edu

Lauren M Nelson, MD

831-535-3397lmgerm01@louisville.edu

More Information

Sponsor

University of Louisville

Last update posted

May 22, 2024

Last verified

May, 2024

Keywords

  • Tibial diaphyseal fracture
  • Nonunion
  • Delayed union

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2024-05-22.