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

Zhejiang University

Status: Not yet enrolling

Conditions: Open tíbia Fracture

Treatments: Procedure: Minimally Invasive Locking Plate Fixation; Procedure: Intramedullary Nail Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT04072094

z2gk

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Minimally Invasive Locking Plate Fixation

Experimental group

Description:

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.

Treatment:

Procedure: Minimally Invasive Locking Plate Fixation

Intramedullary Nail Fixation

Active Comparator group

Description:

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.

Treatment:

Procedure: Intramedullary Nail Fixation