Minimally Invasive Locking Plate Fixation vs Reamed Intramedullary Nail Fixation on Patients With Open Tibia Fracture

Not Applicable

Not yet recruiting

• Conditions: Open tíbia Fracture

• Registration Number: NCT04072094
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed 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 Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-26
• Study First Posted: 2019-08-28
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12
• Study Start: 2020-06
• Primary Completion: 2023-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Ages 18 - 60 years inclusive
• Open diaphyseal fracture
• Gustilo-Anderson Type I, II, IIIA

Exclusion Criteria

• Closed, periarticular or pathological fracture
• Gustilo-Anderson Type IIIB,IIIC
• Patients with concomitant fractures in the ipsilateral limb
• The patient is unable to medically tolerate general anesthesia
• The patient is unable to provide informed consent or comply with completing questionnaires
• Tibia already infected as diagnosed by a surgeon
• The patient has been diagnosed with a severe psychiatric condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LEFS	12 months	failure.

Secondary Outcome Measures

Name	Time	Method
EQ-5D	12 months	Reported Outcome and Quality of Life