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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Open tíbia Fracture
• Intervention / Treatment: Procedure: Minimally Invasive Locking Plate Fixation; Procedure: Intramedullary Nail Fixation

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhao-ming Ye, MD; Phone Number: +86-571-87783553; Email: 2192002@zju.edu.cn
• Study Contact Backup: Name: Ling-ling Sun, MD; Phone Number: +86-571-87783553; Email: sunlingling@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minimally Invasive Locking Plate Fixation; Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used.	Procedure: Minimally Invasive Locking Plate Fixation; Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used.; Other Names: Locking Plate Fixation
Active Comparator: Intramedullary Nail Fixation; Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique.	Procedure: Intramedullary Nail Fixation; Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LEFS	failure.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D	Reported Outcome and Quality of Life	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-12	Reported Outcome and Quality of Life	12 months
Fracture Healing	Fracture healing is measured by the treating surgeon using standard clinical criteria.	12 months
Complications	Soft tissue complications	12 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: The First People's Hospital of Huzhou; Taizhou Hospital; Ningbo No.2 Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: z2gk

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No