Using bone grafts to improve healing in open tibial fractures
Open Tibial Shaft Fractures: Can Packing the Exposed Cortex With Intramedullary Reamings Increase Union Rates
This study is testing if adding bone grafts to the standard treatment can help people with open tibial fractures heal faster and more completely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Trial ID | NCT03891888 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intramedullary bone grafting in enhancing the healing process of open tibial shaft fractures. Patients with these fractures will be randomly assigned to either a control group receiving standard treatment or a study group receiving additional bone grafts made from reamed intramedullary material. The primary focus is to compare the time to full union between the two groups. The study aims to address the high rates of nonunion and delayed union associated with these types of fractures, which can lead to increased healthcare costs and patient suffering.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with Gustillo I, II, or IIIa open tibial shaft fractures requiring intramedullary nailing.
Not a fit: Patients with segmental tibia fractures, significant bone loss, or those unable to have primary closure of the fracture wound may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of nonunion and delayed union in patients with open tibial fractures, leading to improved recovery outcomes.
How similar studies have performed: Previous studies have shown that similar approaches using bone grafts can be effective, but this specific method is being tested for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Louisville, Kentucky and 1 other locations
- University of Louisville Hospital — Louisville, Kentucky, United States (Recruiting)
- University of Louisville Hospital — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Rodolfo Zamora, MD — University of Louisville
- Study coordinator: Rodolfo Zamora, MD
- Email: razamo02@louisville.edu
- Phone: 502-629-5460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.