Actively Recruiting
Intramedullary Bone Grafting for Open Tibial Shaft Fractures
Led by University of Louisville · Updated on 2024-05-22
130
Participants Needed
2
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Intramedullary Bone Grafting for Open Tibial Shaft Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 18 or older
- Open tibia shaft fracture classified as Gustilo I, II, or IIIa
- Fracture to be treated primarily with intramedullary nailing
- Primary closure of the open fracture wound during initial surgery
- Consent to participate in the study
- Able and willing to return for follow-up visits for 6 to 9 months or until healing is confirmed
You will not qualify if you...
- Age under 18 years
- Pregnant patients
- Patients with segmental tibia fractures or bone loss
- Skin defects over the tibia that cannot be closed primarily
- Pathologic fractures of the tibia
- Quadriplegia or paraplegia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
2
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
R
Rodolfo Zamora, MD
CONTACT
S
Salwa M Rashid, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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