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Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures (GitRa)

Primary Purpose

Colles' Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
10-day cast
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colles' Fracture

Eligibility Criteria

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

Inclusion Criteria:

  • Distal radius fracture with intact ulna (except for processus styloideus ulnae)
  • Dorsal angulation 5-40 degrees
  • Axial compression < 4 mm
  • Intra articular step-off < 1 mm
  • Low energy trauma
  • Closed fracture
  • Suitable for treatment with closed reduction and plaster cast fixation

Exclusion Criteria:

  • Fracture older than 3 Days
  • Previously fractured ipsi- or contralateral wrist
  • Dementia
  • Inflammatory joint disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    10-day cast

    1-month cast

    Arm Description

    Removal of plaster cast 10 Days after reduction

    Removal of plaster cast 1 month after reduction

    Outcomes

    Primary Outcome Measures

    Radiographic displacement
    Change in dorsal angulation, radial angulation and axial compression between follow-ups.

    Secondary Outcome Measures

    Grip strength
    Grip strength compared to uninjured side at 1, 4 and 12 months
    Range of motion
    Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months.
    Assessment of pain intensity
    Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months
    Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.
    The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group),

    Full Information

    First Posted
    June 1, 2016
    Last Updated
    June 14, 2016
    Sponsor
    Uppsala University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02798614
    Brief Title
    Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
    Acronym
    GitRa
    Official Title
    A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.
    Detailed Description
    Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    10-day cast
    Arm Type
    Active Comparator
    Arm Description
    Removal of plaster cast 10 Days after reduction
    Arm Title
    1-month cast
    Arm Type
    No Intervention
    Arm Description
    Removal of plaster cast 1 month after reduction
    Intervention Type
    Device
    Intervention Name(s)
    10-day cast
    Intervention Description
    Removal of plaster cast fixation 10 days after reduction
    Primary Outcome Measure Information:
    Title
    Radiographic displacement
    Description
    Change in dorsal angulation, radial angulation and axial compression between follow-ups.
    Time Frame
    At admission, 10 days, 1 month and 12 months
    Secondary Outcome Measure Information:
    Title
    Grip strength
    Description
    Grip strength compared to uninjured side at 1, 4 and 12 months
    Time Frame
    Uninjured side. Injured side at 1, 4 , 12 months
    Title
    Range of motion
    Description
    Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months.
    Time Frame
    Uninjured side. Injured side at 1, 4 and 12 months
    Title
    Assessment of pain intensity
    Description
    Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months
    Time Frame
    10 days, 1, 4 and 12 months
    Title
    Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.
    Description
    The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group),
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Distal radius fracture with intact ulna (except for processus styloideus ulnae) Dorsal angulation 5-40 degrees Axial compression < 4 mm Intra articular step-off < 1 mm Low energy trauma Closed fracture Suitable for treatment with closed reduction and plaster cast fixation Exclusion Criteria: Fracture older than 3 Days Previously fractured ipsi- or contralateral wrist Dementia Inflammatory joint disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Albert Christersson, MD
    Organizational Affiliation
    Department of Orthopaedics, University Hospital of Uppsala
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27871284
    Citation
    Christersson A, Larsson S, Ostlund B, Sanden B. Radiographic results after plaster cast fixation for 10 days versus 1 month in reduced distal radius fractures: a prospective randomised study. J Orthop Surg Res. 2016 Nov 21;11(1):145. doi: 10.1186/s13018-016-0478-7.
    Results Reference
    derived

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    Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

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