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

NCT04072094 | Unknown DMC

• 1 other identifier: z2gk
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Open tíbia Fracture

Outcome Measures

Primary Outcomes (1)

• LEFS

  failure.

  12 months

Secondary Outcomes (1)

• EQ-5D

  12 months

Other Outcomes (3)

• SF-12

  12 months

• Fracture Healing

  12 months

• Complications

  12 months

Study Arms (2)

Minimally Invasive Locking Plate Fixation

EXPERIMENTAL

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

Intramedullary Nail Fixation

ACTIVE COMPARATOR

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

Interventions

Minimally Invasive Locking Plate Fixation PROCEDURE

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.

Also known as: Locking Plate Fixation

Minimally Invasive Locking Plate Fixation

Intramedullary Nail Fixation PROCEDURE

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.

Intramedullary Nail Fixation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Central Study Contacts

Zhao-ming Ye, MD

CONTACT

+86-571-87783553; 2192002@zju.edu.cn

Ling-ling Sun, MD

CONTACT

+86-571-87783553; sunlingling@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 28, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2025
• Last Updated: May 12, 2020

Record last verified: 2019-08