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A Prospective Randomized Trial Comparing the Effect of Minimally Invasive Locking Plate Fixation and Reamed Intramedullary Nail Fixation on Patients With Gustilo I-III A Open Tibia Fracture
The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.
The best fixation method for open tibial fractures remains controversial. The current standard treatment options recommended the use of intramedullary nail for treating such fractures. Recent studies also showed favorable results for the use of plates in managing open tibial fractures. However, it is unknown whether locking plate or intramedullary nail fixation will result in lower complication rates and better function. This study is a prospective, randomized trial to compare the safety and efficiency of minimally invasive plate osteosynthesis and reamed intramedullary nails in treating type I-II open tibial shaft fractures. The investigators hypothesize that neither intervention resulted in a superior disability rating at 12 months. Outcomes evaluated will include the rate of infection, the number of re-hospitalization for the complication, the time to bone healing, Patient-Reported outcome and quality of life and other complications.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Start Date
June 1, 2020
Primary Completion Date
June 1, 2023
Completion Date
June 1, 2025
Last Updated
May 12, 2020
300
ESTIMATED participants
Minimally Invasive Locking Plate Fixation
PROCEDURE
Intramedullary Nail Fixation
PROCEDURE
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Data Source & Attribution
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