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Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail

Primary Purpose

Open tíbia Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
External fixator
Intramedullary nail
Sponsored by
Fabio lucas rodrigues
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open tíbia Fracture focused on measuring Tibial fractures., Fracture fixation., External fixators., Intramedullary., Quality of life.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the investigators considered those with shaft compound fracture of the tibia (occurring two inches below the knee and two inches above the ankle), that per the classification Gustillo and Anderson were grades I, II, and IIIA, in patients with a mature skeleton.

Exclusion Criteria:

  • The presence of extensive skin lesions and soft tissue or arterial injury requiring surgical repair (Grades IIIB and C) in the initial care, other fractures with the exception of the fibula, or the presence of wounds with signs of infection in the period between the accident and definitive surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    Intramedullary nail

    External fixator

    Arm Description

    Fractures treated with intramedullary reamed nail

    Tibial fractures treated with biplanar external fixation

    Outcomes

    Primary Outcome Measures

    Bone healing
    bone formation in 3 cortical through the fracture in x ray

    Secondary Outcome Measures

    Quality of life
    SF 36

    Full Information

    First Posted
    February 3, 2014
    Last Updated
    February 18, 2014
    Sponsor
    Fabio lucas rodrigues
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02064595
    Brief Title
    Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail
    Official Title
    TREATMENT OF EXPOSED FRACTURES OF TIBIA: A COMPARATIVE STUDY BETWEEN BIPLANE EXTERNAL FIXATOR AND LOCKED INTRAMEDULLARY NAIL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Fabio lucas rodrigues

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this research is to prospectively evaluate a group of patients with shaft compound fracture of the tibia, treated with a biplanar external fixator or locked intramedullary reamed nail. The investigators evaluate the quality of life, bone healing and postoperative complications.
    Detailed Description
    68 patients will be followed for a minimum of 12 months and a maximum of 24 months. As inclusion criterion, the investigators considered those with shaft compound fracture of the tibia (occurring two inches below the knee and two inches above the ankle), that per the classification Gustillo and Anderson were grades I, II, and IIIA, in patients with a mature skeleton. The presence of extensive skin lesions and soft tissue or arterial injury requiring surgical repair (Grades IIIB and C) in the initial care, other fractures with the exception of the fibula, or the presence of wounds with signs of infection in the period between the accident and definitive surgery, were used as exclusion criteria. The patients will be treated in two ways, biplanar external fixator (Group I) and locked intramedullary reamed nail in the tibia (Group II), being divided into these groups by simple randomization. During initial care in the emergency room, antibiotic prophylaxis, cleaning, debridement, and external splinting of the fracture were performed by staff on duty. There was no interference with respect to the type of assembly to be used in the initial care, leaving the doctor on duty free to use the type of external fixators which he is most used to. Patients remained hospitalized and received first-generation cephalosporin and dressing of the wound daily. In the 4th to the 7th postoperative day after the initial procedure, the patient underwent another surgery to reassemble the biplanar external fixation or to convert to the locked intramedullary reamed nail. External fixation consists of the biplanar assembly with six Schanz pins of six millimeters. The placement of these follows the sequence: two proximal to the fracture in different planes and two distal similar to the first. The investigators performed reduction and placement of two bars, one medial and one lateral. Assessed by radiography, two more pins were then introduced into the medial rod, ending with the fixation of a tube-to-tube rod at the level of the fracture. For fixation by locked intramedullary reamed nail, the access path of introduction used was through the patellar tendon, with the knee flexed at 100 degrees on a radiotransparent table.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open tíbia Fracture
    Keywords
    Tibial fractures., Fracture fixation., External fixators., Intramedullary., Quality of life.

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Intramedullary nail
    Arm Type
    Other
    Arm Description
    Fractures treated with intramedullary reamed nail
    Arm Title
    External fixator
    Arm Type
    Active Comparator
    Arm Description
    Tibial fractures treated with biplanar external fixation
    Intervention Type
    Procedure
    Intervention Name(s)
    External fixator
    Intervention Description
    Treatment with external fixation
    Intervention Type
    Procedure
    Intervention Name(s)
    Intramedullary nail
    Intervention Description
    Fracture treated with intramedullary nail
    Primary Outcome Measure Information:
    Title
    Bone healing
    Description
    bone formation in 3 cortical through the fracture in x ray
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Quality of life
    Description
    SF 36
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Infection
    Description
    Productive fistula, phlogistics signals
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the investigators considered those with shaft compound fracture of the tibia (occurring two inches below the knee and two inches above the ankle), that per the classification Gustillo and Anderson were grades I, II, and IIIA, in patients with a mature skeleton. Exclusion Criteria: The presence of extensive skin lesions and soft tissue or arterial injury requiring surgical repair (Grades IIIB and C) in the initial care, other fractures with the exception of the fibula, or the presence of wounds with signs of infection in the period between the accident and definitive surgery

    12. IPD Sharing Statement

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    Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail

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