RecruitingNot Applicable

Intramedullary Bone Grafting for Open Tibial Shaft Fractures

United States130 participantsStarted 2020-03-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Radiographic Union at 6 months

Timeframe: 6 months

Radiographic Union at 4 months

Timeframe: 4 months

Trial details

NCT IDNCT03891888

SponsorUniversity of Louisville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02

Contact for this trial

Rodolfo Zamora, MD

502-629-5460 razamo02@louisville.edu