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Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

Primary Purpose

Fracture Clavicle

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open Reduction Internal Fixation (ORIF)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Clavicle

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults (over 16 years old) including both sexes.
  • Acute fractures within 3 weeks of injury.
  • Isolated & closed fractures.

Exclusion Criteria:

  • Pathological fracture of distal clavicle.
  • Deteriorated general health.
  • Previous history of dysfunction with the affected shoulder.
  • Incomplete medical records or lost to follow up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    A- hook plate

    B- tightrope

    Arm Description

    All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with hook plate. X-ray was applied to check the grade of reduction before the operation is completed.

    All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with tightrope. X-ray was applied to check the grade of reduction before the operation is completed.

    Outcomes

    Primary Outcome Measures

    Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months
    The DASH is a self-administered questionnaire that consists of thirty core questions and an optional additional eight questions assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, with lower scores correlating to minimal impairment and higher scores indicating more impairment. The cumulative DASH score is scaled from 0 to 100, with higher scores indicating more disability

    Secondary Outcome Measures

    Fracture Healing
    Radiological evaluation of the fracture by using antero-posterior and axillary views x-ray
    Blood loss
    Recording of the blood loss amount during surgery in milliliters.
    Radiation time
    Calculation of the exposure time to radiations during surgery in minutes.
    Skin condition
    Evaluation of skin condition of the surgical incision by clinical inspection

    Full Information

    First Posted
    December 10, 2018
    Last Updated
    February 19, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03773848
    Brief Title
    Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle
    Official Title
    Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2019 (Anticipated)
    Primary Completion Date
    January 1, 2021 (Anticipated)
    Study Completion Date
    February 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    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
    to compare the clinical & radiological outcomes of hook plate & tightrope fixation in fracture of lateral third clavicle.
    Detailed Description
    Adult clavicle fractures account for 4% to 10% of fractures. Distal clavicle fractures occurs in 25% to 30% of all clavicle fracture.The management of fractures of the distal clavicle has been a matter of debate in literature. Neer in 1968 suggested a new classification and proposed general treatment guidelines . Type I and type III fractures are generally treated non-operatively. For type II fractures, surgical management is the treatment of choice .There are numerous operative techniques reported in the past. The methods of surgical treatment could be summarised as follows: Fixation in terms of K-wires and different pins such as the Steinmann pin, and Knowles pin. This fixation could also be augmented with concomitant tension band wires Coracoclavicular indirect fixation with the use of screws, suture anchors, Dacron graft or Mersilene tape Open reduction and clavicular plate fixation with the use of different plate systems such as the Balser plate,locked plate,hook plate, etc. Different surgical techniques have their own advantages and disadvantages With more than 20 techniques described so far, no single fixation is ideal and perfect. There is still no consensus regarding the best surgical method to fix these fracture ,the investigators choose two of the most common of these methods and evaluate & compare best radiological & clinical outcomes of both.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A- hook plate
    Arm Type
    Experimental
    Arm Description
    All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with hook plate. X-ray was applied to check the grade of reduction before the operation is completed.
    Arm Title
    B- tightrope
    Arm Type
    Experimental
    Arm Description
    All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with tightrope. X-ray was applied to check the grade of reduction before the operation is completed.
    Intervention Type
    Procedure
    Intervention Name(s)
    Open Reduction Internal Fixation (ORIF)
    Intervention Description
    Open Reduction Internal Fixation (ORIF) of fracture lateral third clavicle by hook plate & tightrope
    Primary Outcome Measure Information:
    Title
    Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months
    Description
    The DASH is a self-administered questionnaire that consists of thirty core questions and an optional additional eight questions assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, with lower scores correlating to minimal impairment and higher scores indicating more impairment. The cumulative DASH score is scaled from 0 to 100, with higher scores indicating more disability
    Time Frame
    at 6 weeks & 6 months post-operatively.
    Secondary Outcome Measure Information:
    Title
    Fracture Healing
    Description
    Radiological evaluation of the fracture by using antero-posterior and axillary views x-ray
    Time Frame
    at 6 weeks & 6 months post-operatively.
    Title
    Blood loss
    Description
    Recording of the blood loss amount during surgery in milliliters.
    Time Frame
    Intra-operatively
    Title
    Radiation time
    Description
    Calculation of the exposure time to radiations during surgery in minutes.
    Time Frame
    Intra-operatively
    Title
    Skin condition
    Description
    Evaluation of skin condition of the surgical incision by clinical inspection
    Time Frame
    at 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults (over 16 years old) including both sexes. Acute fractures within 3 weeks of injury. Isolated & closed fractures. Exclusion Criteria: Pathological fracture of distal clavicle. Deteriorated general health. Previous history of dysfunction with the affected shoulder. Incomplete medical records or lost to follow up.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David
    Phone
    +201221748069
    Email
    davidmounir1@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25200315
    Citation
    Flinkkila T, Heikkila A, Sirnio K, Pakarinen H. TightRope versus clavicular hook plate fixation for unstable distal clavicular fractures. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):465-9. doi: 10.1007/s00590-014-1526-9. Epub 2014 Sep 9.
    Results Reference
    background
    PubMed Identifier
    24675020
    Citation
    Haque S, Khan A, Sharma A, Sundararajan S. Technical tip: tightrope fixation of neer type II distal clavicle fracture supported by a case series. Pol Orthop Traumatol. 2014 Mar 27;79:19-22.
    Results Reference
    background
    PubMed Identifier
    28131682
    Citation
    Lee W, Choi CH, Choi YR, Lim KH, Chun YM. Clavicle hook plate fixation for distal-third clavicle fracture (Neer type II): comparison of clinical and radiologic outcomes between Neer types IIA and IIB. J Shoulder Elbow Surg. 2017 Jul;26(7):1210-1215. doi: 10.1016/j.jse.2016.11.046. Epub 2017 Jan 26.
    Results Reference
    background
    PubMed Identifier
    28801112
    Citation
    Yan HW, Li L, Wang RC, Yang Y, Xie Y, Tang J, Shi ZY. Clinical efficacies of coracoclavicular ligament reconstruction using suture anchor versus hook plate in the treatment of distal clavicle fracture. Orthop Traumatol Surg Res. 2017 Dec;103(8):1287-1293. doi: 10.1016/j.otsr.2017.07.006. Epub 2017 Aug 8.
    Results Reference
    background

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    Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

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