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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04072094
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Zhao-ming Ye, MD
Phone +86-571-87783553
Email 2192002@zju.edu.cn
Status Not yet recruiting
Phase N/A
Start date June 2020
Completion date June 2025

See also
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Not yet recruiting NCT06288139 - Management of Open Fracture Tibia in Teenagers
Not yet recruiting NCT05766670 - Intramedullary Calcium Sulfate Antibiotic Depot Phase 3
Completed NCT02064595 - Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail N/A