RecruitingNot ApplicableNCT03891888

Intramedullary Bone Grafting for Open Tibial Shaft Fractures

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

Sponsor

University of Louisville

Enrollment

130 participants

Start Date

Mar 26, 2020

Study Type

INTERVENTIONAL

Conditions

Tibial Fractures Nonunion of Fracture Delayed Union of Fracture

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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

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Interventions

PROCEDUREIntramedullary 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