Intramedullary Bone Grafting for Open Tibial Shaft Fractures

Launched by UNIVERSITY OF LOUISVILLE · Mar 26, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how effective a specific treatment is for patients with open fractures of the tibia, which is the larger bone in your lower leg. The trial will compare two groups of patients who are undergoing a common surgery called intramedullary nailing to fix their fractures. One group will receive an additional treatment called a bone graft, which is made from the leftover bone material during the surgery. The main goal is to see if this bone graft helps patients heal faster and achieve full union of the fracture compared to those who do not receive the graft.

To be eligible for this study, participants must be at least 18 years old and have a certain type of open tibia fracture that will be treated with intramedullary nailing. They should also be able to return for follow-up visits for about 6 to 9 months to monitor their healing. Patients who are pregnant, under 18, or have certain complications related to their fractures may not be able to participate. If you join the study, you can expect close monitoring of your recovery and the chance to contribute to important research that could improve treatment for future patients with similar injuries.

Gender

ALL

Eligibility 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