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Minimally Invasive Fixation for Distal Radius Fractures (DRF)

Primary Purpose

Distal Radius Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minimal invasive surgical fixation of distal radius Fractures
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

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

Inclusion Criteria:

  1. patients with unstable distal radial fracture
  2. skeletally mature Patients.
  3. Acute fractures within one weeks of injury

Exclusion Criteria:

  1. contaminated open fractures.
  2. fractures associated with vascular injury requiring repair, and suspected pathologic Fracture

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Minimally invasive fixation

    Arm Description

    Minimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults

    Outcomes

    Primary Outcome Measures

    Fracture healing
    Rate of fracture healing
    Wrist function
    Percentage of restoration of wrist function

    Secondary Outcome Measures

    Fracture compilations
    Percentage of fracture healing compilations

    Full Information

    First Posted
    December 1, 2021
    Last Updated
    January 30, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05175118
    Brief Title
    Minimally Invasive Fixation for Distal Radius Fractures
    Acronym
    DRF
    Official Title
    Minimally Invasive Surgical Fixation for Unstable Fractures of the Distal End Radius in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 20, 2024 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    October 2025 (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
    Minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. Under conditions of no cutting of fracture fragments, no blood supply compromise in the fracture fragments
    Detailed Description
    Distal radial fracture is common fracture and internal fixation needed in many cases so we use minimally invasive fixation in this study to minimize open surgery compilations

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Minimally invasive fixation
    Arm Type
    Other
    Arm Description
    Minimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults
    Intervention Type
    Device
    Intervention Name(s)
    Minimal invasive surgical fixation of distal radius Fractures
    Intervention Description
    Fixation of distal radius Fractures by minimal invasive technique
    Primary Outcome Measure Information:
    Title
    Fracture healing
    Description
    Rate of fracture healing
    Time Frame
    6 minths
    Title
    Wrist function
    Description
    Percentage of restoration of wrist function
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Fracture compilations
    Description
    Percentage of fracture healing compilations
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients with unstable distal radial fracture skeletally mature Patients. Acute fractures within one weeks of injury Exclusion Criteria: contaminated open fractures. fractures associated with vascular injury requiring repair, and suspected pathologic Fracture
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ab Ma Ghozaly
    Phone
    01555167657
    Email
    Abdalraoofmahmoud4@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kh M Mustafa
    Phone
    01001956942
    Email
    khaledbalam@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ab Ma Ghozaly
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Study analytic results
    Citations:
    PubMed Identifier
    29231799
    Citation
    Liverneaux PA. The minimally invasive approach for distal radius fractures and malunions. J Hand Surg Eur Vol. 2018 Feb;43(2):121-130. doi: 10.1177/1753193417745259. Epub 2017 Dec 12.
    Results Reference
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    PubMed Identifier
    25723576
    Citation
    Chmielnicki M, Prokop A. [New minimally invasive approach for palmar plating in distal radius fractures]. Z Orthop Unfall. 2015 Feb;153(1):25-8. doi: 10.1055/s-0034-1383103. Epub 2015 Feb 27. German.
    Results Reference
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    PubMed Identifier
    29368237
    Citation
    Igeta Y, Vernet P, Facca S, Naroura I, Hidalgo Diaz JJ, Diaz JJH, Liverneaux PA. The minimally invasive flexor carpi radialis approach: a new perspective for distal radius fractures. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1515-1522. doi: 10.1007/s00590-018-2124-z. Epub 2018 Jan 24. Erratum In: Eur J Orthop Surg Traumatol. 2018 Mar 3;:. Diaz JJH [corrected to Hidalgo Diaz JJ].
    Results Reference
    background
    PubMed Identifier
    24436782
    Citation
    Slutsky DJ. Outcomes assessment in wrist surgery. J Wrist Surg. 2013 Feb;2(1):1-4. doi: 10.1055/s-0033-1333892. No abstract available.
    Results Reference
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    Minimally Invasive Fixation for Distal Radius Fractures

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