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Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate

Primary Purpose

Closed Fracture of Shaft of Clavicle

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open Reduction Internal Fixation superior plate
Open Reduction Internal Fixation anteroinferior plate
Sponsored by
UMAE Hospital de Traumatologia y Ortopedia de Puebla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Fracture of Shaft of Clavicle focused on measuring midshaft clavicle fracture, functional outcome, anteroinferior plate, superior plate, reconstruction plate

Eligibility Criteria

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

Inclusion Criteria:

  • traumatic fracture
  • ao 15 b1 and 15 b2
  • no previous shoulder lesions
  • no further 7 days fractures
  • closed fracture

Exclusion Criteria:

  • calcium diseases
  • Previous shoulder pain
  • other fractures associated

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    superior group

    anteroinferior group

    Arm Description

    this group with midshaft clavicle fracture were treated with superior reconstruction plate

    this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate

    Outcomes

    Primary Outcome Measures

    Disabilities of Arm Shoulder and Hand score (DASH)
    we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
    Disabilities of Arm Shoulder and Hand score (DASH)
    we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
    Disabilities of Arm Shoulder and Hand score (DASH)
    we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
    Disabilities of Arm Shoulder and Hand score (DASH)
    we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability

    Secondary Outcome Measures

    Visual Analogue Scale score (VAS)
    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
    Visual Analogue Scale score (VAS)
    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
    Visual Analogue Scale score (VAS)
    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
    Visual Analogue Scale score (VAS)
    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain

    Full Information

    First Posted
    April 30, 2018
    Last Updated
    May 10, 2018
    Sponsor
    UMAE Hospital de Traumatologia y Ortopedia de Puebla
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03533634
    Brief Title
    Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate
    Official Title
    Functional Outcome in Midshaft Clavicle Fracture Patients, Treated With Superior Versus Anteroinferior Reconstruction Plate. Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2015 (Actual)
    Primary Completion Date
    September 30, 2017 (Actual)
    Study Completion Date
    January 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    UMAE Hospital de Traumatologia y Ortopedia de Puebla

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
    Detailed Description
    The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first technique was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Closed Fracture of Shaft of Clavicle
    Keywords
    midshaft clavicle fracture, functional outcome, anteroinferior plate, superior plate, reconstruction plate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized clinical trial
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    the patient and the outcomes analyzer were masked
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    superior group
    Arm Type
    Experimental
    Arm Description
    this group with midshaft clavicle fracture were treated with superior reconstruction plate
    Arm Title
    anteroinferior group
    Arm Type
    Experimental
    Arm Description
    this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate
    Intervention Type
    Procedure
    Intervention Name(s)
    Open Reduction Internal Fixation superior plate
    Intervention Description
    3.5mm superior reconstruction plate
    Intervention Type
    Procedure
    Intervention Name(s)
    Open Reduction Internal Fixation anteroinferior plate
    Intervention Description
    3.5mm anteroinferior reconstruction plate
    Primary Outcome Measure Information:
    Title
    Disabilities of Arm Shoulder and Hand score (DASH)
    Description
    we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
    Time Frame
    30 days after surgery
    Title
    Disabilities of Arm Shoulder and Hand score (DASH)
    Description
    we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
    Time Frame
    60 days after surgery
    Title
    Disabilities of Arm Shoulder and Hand score (DASH)
    Description
    we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
    Time Frame
    90 days after surgery
    Title
    Disabilities of Arm Shoulder and Hand score (DASH)
    Description
    we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
    Time Frame
    365 days after surgery
    Secondary Outcome Measure Information:
    Title
    Visual Analogue Scale score (VAS)
    Description
    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
    Time Frame
    30 days after surgery
    Title
    Visual Analogue Scale score (VAS)
    Description
    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
    Time Frame
    60 days after surgery
    Title
    Visual Analogue Scale score (VAS)
    Description
    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
    Time Frame
    90 days after surgery
    Title
    Visual Analogue Scale score (VAS)
    Description
    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
    Time Frame
    365 days after surgery

    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: traumatic fracture ao 15 b1 and 15 b2 no previous shoulder lesions no further 7 days fractures closed fracture Exclusion Criteria: calcium diseases Previous shoulder pain other fractures associated
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jose A Manrique, MD
    Organizational Affiliation
    UMAE Hospital de Traumatologia y Ortopedia de Puebla
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gustavo Rivera Saldivar, MD
    Organizational Affiliation
    UMAE Hospital de Traumatologia y Ortopedia de Puebla
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate

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