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

Open tíbia Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04072094
• Other study ID #: z2gk
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: June 2025

Study information

• Verified date: August 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zhao-ming Ye, MD
• Phone: +86-571-87783553
• Email: 2192002[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Open tíbia Fracture
• Tibial Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First People's Hospital Affiliated to Huzhou University, Ningbo No.2 Hospital, Taizhou Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SF-12	Reported Outcome and Quality of Life	12 months
Other	Fracture Healing	Fracture healing is measured by the treating surgeon using standard clinical criteria.	12 months
Other	Complications	Soft tissue complications	12 months
Primary	LEFS	failure.	12 months
Secondary	EQ-5D	Reported Outcome and Quality of Life	12 months