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Conservative Treatment vs. Volar Plating of Distal Radius Fractures (DRF)

Primary Purpose

Distal Radius Fractures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Volar plating
Conservative treatment
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fractures

Eligibility Criteria

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

Inclusion Criteria:

  • patients over 50 years-old
  • primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)
  • primary reduction of fracture is acceptable considering primary conservative treatment

Exclusion Criteria:

  • bilateral and open fractures and fractures with neurovascular compromise
  • other major concurrent fracture necessitating treatment of any kind
  • patients under 50 years of age
  • previous ipsilateral distal radius fracture
  • inflammatory joint disease
  • significant radiocarpal-joint degeneration
  • patient's bad co-operation or major co-morbidity making an operation contraindicated

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Volar plating

    Conservative treatment

    Arm Description

    Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.

    Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.

    Outcomes

    Primary Outcome Measures

    Difference of DASH-score between two study groups
    Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity

    Secondary Outcome Measures

    Difference of radiological parameters between two study groups
    Dorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint

    Full Information

    First Posted
    November 7, 2016
    Last Updated
    December 9, 2016
    Sponsor
    University of Oulu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02990052
    Brief Title
    Conservative Treatment vs. Volar Plating of Distal Radius Fractures
    Acronym
    DRF
    Official Title
    Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Oulu

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture
    Detailed Description
    Volar plating has became as a standard approach for treating unstable distal radius fractures. The incidence of surgically treated patients with distal radius fractures has increased many fold from the beginning of this millennium, owing mostly to increased number of volar platings. The most striking increase of plate fixations has occurred in older patient groups, especially in females. With volar fixed-angle plate, very near-anatomic, stable fixation with relatively low complication rate, can be achieved even in osteoporotic bone. There are only few randomized, prospective studies comparing results of volar plating and conservative treatment, comparing patients aged over 65 years. Quite little is known of the results comparing conservative treatment and volar plating in patients aged below 65 years. Main goal of our study was to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture in patients aged over 50 years an older.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Volar plating
    Arm Type
    Active Comparator
    Arm Description
    Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.
    Arm Title
    Conservative treatment
    Arm Type
    Active Comparator
    Arm Description
    Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.
    Intervention Type
    Procedure
    Intervention Name(s)
    Volar plating
    Intervention Description
    Open reduction and volar fixed-angle plate fixation of distal radius fracture
    Intervention Type
    Procedure
    Intervention Name(s)
    Conservative treatment
    Intervention Description
    Closed reduction & casting of distal radius fracture
    Primary Outcome Measure Information:
    Title
    Difference of DASH-score between two study groups
    Description
    Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity
    Time Frame
    2 year observation
    Secondary Outcome Measure Information:
    Title
    Difference of radiological parameters between two study groups
    Description
    Dorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint
    Time Frame
    2 year observation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients over 50 years-old primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2) primary reduction of fracture is acceptable considering primary conservative treatment Exclusion Criteria: bilateral and open fractures and fractures with neurovascular compromise other major concurrent fracture necessitating treatment of any kind patients under 50 years of age previous ipsilateral distal radius fracture inflammatory joint disease significant radiocarpal-joint degeneration patient's bad co-operation or major co-morbidity making an operation contraindicated

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Conservative Treatment vs. Volar Plating of Distal Radius Fractures

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