search
Back to results

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

Primary Purpose

Open tíbia Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minimally Invasive Locking Plate Fixation
Intramedullary Nail Fixation
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open tíbia Fracture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Minimally Invasive Locking Plate Fixation

    Intramedullary Nail Fixation

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    LEFS
    failure.

    Secondary Outcome Measures

    EQ-5D
    Reported Outcome and Quality of Life

    Full Information

    First Posted
    August 19, 2019
    Last Updated
    May 9, 2020
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    Taizhou Hospital, Ningbo No.2 Hospital, The First People's Hospital of Huzhou
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04072094
    Brief Title
    Minimally Invasive Locking Plate Fixation vs Reamed Intramedullary Nail Fixation on Patients With Open Tibia Fracture
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    Taizhou Hospital, Ningbo No.2 Hospital, The First People's Hospital of Huzhou

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open tíbia Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Minimally Invasive Locking Plate Fixation
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Intramedullary Nail Fixation
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Minimally Invasive Locking Plate Fixation
    Other Intervention Name(s)
    Locking Plate Fixation
    Intervention 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Intramedullary Nail Fixation
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    LEFS
    Description
    failure.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    EQ-5D
    Description
    Reported Outcome and Quality of Life
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    SF-12
    Description
    Reported Outcome and Quality of Life
    Time Frame
    12 months
    Title
    Fracture Healing
    Description
    Fracture healing is measured by the treating surgeon using standard clinical criteria.
    Time Frame
    12 months
    Title
    Complications
    Description
    Soft tissue complications
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhao-ming Ye, MD
    Phone
    +86-571-87783553
    Email
    2192002@zju.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ling-ling Sun, MD
    Phone
    +86-571-87783553
    Email
    sunlingling@zju.edu.cn

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs