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Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

Primary Purpose

Distal Radius Fracture, Multiple Trauma, Elderly Person Maltreatment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
External fixation in treatment the distal radius fracture
Sponsored by
Faculdade de Medicina do ABC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • skeletally mature patients, elderly (60 y.o. or more)
  • all with a diagnosis of unstable distal radius fractures (AO type A or C)
  • associated a multiple injured ( polytrauma ).

Exclusion Criteria:

  • ongoing chemo or radiotherapy,
  • mental illness,
  • alcohol abuse.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Bridging (control group)

    Nonbridging (tested group)

    Arm Description

    External fixation in treatment the distal radius fracture

    External fixation in treatment the distal radius fracture improve grip strength?

    Outcomes

    Primary Outcome Measures

    Grip strenght
    use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist

    Secondary Outcome Measures

    range of wrist motion
    use the specific goniometer to measure the arc of movement the wrist
    Radiograph assesment
    Measure ulna and radial shortening, tilt palmar
    DASH Questionnaire
    measure life quality
    VAS (visual analog scale)
    patient reported outcome (pain) in scale interval (0 until 10)

    Full Information

    First Posted
    May 11, 2017
    Last Updated
    May 12, 2017
    Sponsor
    Faculdade de Medicina do ABC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03154424
    Brief Title
    Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients
    Official Title
    Bridging Versus Non-bridging Dynamic External Fixation in Early Total Care Treatment Unstable Distal Radius Fractures in Elderly Polytrauma Patients: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    May 1, 2017 (Actual)
    Study Completion Date
    May 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Faculdade de Medicina do ABC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A single center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital, Santo Andre, Brazil. Two implants used for fixation in closed reduction of distal radius fractures were compared: the bridging dynamic Galaxy Wrist external fixator (Orthofix®, Verona) and the non-bridging Galaxy wrist external fixator system (Orthofix®, Verona).
    Detailed Description
    Dynamic external fixator in the ETC (Early Total Care) of unstable DRFs (distal radius fractures) may be a good choice of treatment. Because it's fast, safe, minimally invasive and easily performed method, it could help in the inflammatory systemic response to trauma, unable earlier functional recovery and shorten the hospitalization time of these patients (elderly and polytrauma). From this, in this study to obtain relevant information about each type of treatment, avoid possible selection bias, information and confusion. Choose a reproducible and effective method (external fixator), which presents a cost / benefit compatible with our reality, but that generates doubt the best way to apply this "bridging" which is already used and that will be our control group and "non-bridging", which will be the group to be tested. Rather than establishing the actual value of each of these procedures, is necessary to optimize and improve the quality of life of these patients in order to return to your personal and professional activities as soon as possible.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Distal Radius Fracture, Multiple Trauma, Elderly Person Maltreatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Patients were randomized by drawing lots currency (Face = A - treatment with fixation "non-bridging"; Crown = B - Treatment with the method "bridging"), which were printed and placed in sealed envelopes before the study started.
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bridging (control group)
    Arm Type
    Placebo Comparator
    Arm Description
    External fixation in treatment the distal radius fracture
    Arm Title
    Nonbridging (tested group)
    Arm Type
    Active Comparator
    Arm Description
    External fixation in treatment the distal radius fracture improve grip strength?
    Intervention Type
    Procedure
    Intervention Name(s)
    External fixation in treatment the distal radius fracture
    Intervention Description
    Compare two techniques
    Primary Outcome Measure Information:
    Title
    Grip strenght
    Description
    use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    range of wrist motion
    Description
    use the specific goniometer to measure the arc of movement the wrist
    Time Frame
    12 months
    Title
    Radiograph assesment
    Description
    Measure ulna and radial shortening, tilt palmar
    Time Frame
    12 months
    Title
    DASH Questionnaire
    Description
    measure life quality
    Time Frame
    12 months
    Title
    VAS (visual analog scale)
    Description
    patient reported outcome (pain) in scale interval (0 until 10)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: skeletally mature patients, elderly (60 y.o. or more) all with a diagnosis of unstable distal radius fractures (AO type A or C) associated a multiple injured ( polytrauma ). Exclusion Criteria: ongoing chemo or radiotherapy, mental illness, alcohol abuse.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

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