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Radiological vs Clinical Outcome in DRF

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgery of distal radius fracture
Reduction and cast treatment of distal radius fracture
Sponsored by
Sundsvall Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna.

Exclusion Criteria:

  • Dementia
  • Previous fracture to the ipsilateral wrist
  • Open fracture
  • Other concomitant or existing damage or injury to the wrist
  • Galeazzi fracture
  • Rheumatoid arthritis
  • Alcohol or drug abuse
  • Neurologic impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Treatment protocol

    Arm Description

    All patients were treated according to the treatment protocol with cast for minimally displaced fractures and surgery for displaced fractures.

    Outcomes

    Primary Outcome Measures

    quickDASH
    The DASH is a 30-item PROM questionnaire that evaluates the upper extremity [115]. The qDASH is a shortened version with 11 questions that can be used instead of the full 30-item questionnaire [114]. Both are validated for use in upper extremity disorders [114,115]. Neither is specific for wrist function and both yield scores from 0 to 100, where lower scores indicate a better outcome.
    Range of motion
    The active ROM of the radiocarpal joint and the radioulnar joints were measured in both hands using a standard goniometer. The arcs of flexion-extension, pronation-supination and radial-ulnar deviation were recorded. Total ROM was calculated as the sum of these three arcs. The loss of ROM in the fractured wrist was expressed in angular degrees compared to the contralateral uninjured wrist [126]. Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.
    Grip strength
    Grip strength was measured in a sitting position with the elbow in 90° of flexion, neutral rotation and wrist 0°-30° extension using a JAMAR dynamometer [122]. To prevent it from falling, the examiner may support the JAMAR dynamometer. Both hands are examined, starting with the uninjured hand. Three strength tests were conducted during the assessment of grip strength, with the mean score of the three tests recorded for analysis. Grip strength was adjusted by 10% for the non-dominant hand [123]. The contralateral wrist was used as an internal control. Grip strength was expressed as a percentage (the ratio to the uninjured wrist) and the absolute loss in kilograms comparing the fractured wrist to the uninjured wrist. Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2022
    Last Updated
    September 23, 2022
    Sponsor
    Sundsvall Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05558306
    Brief Title
    Radiological vs Clinical Outcome in DRF
    Official Title
    Association Between Radiographic and Clinical Outcome in Distal Radius Fractures: A Prospective Cohort Study With a 1-year Follow-up in 368 Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (Actual)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    September 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sundsvall Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Background: Several studies have investigated the degree of final displacement and its association with clinical outcome. There is still no consensus on the importance of radiological outcome and published studies do not use the same criteria for an acceptable alignment. Previous reports have used a linear or a dichotomized exposure in the statistical analysis, but no study has investigated a nonlinear association. Methods: We included 438 patients treated for a distal radius fracture (DRF) with either reduction and cast immobilization or surgery. Radiographic outcomes were determined by radiographs 3 months after the injury. Clinical outcome was determined by QuickDASH (qDASH), ROM and grip strength at 1-year after the injury. Nonlinear correlations were analysed with cubic splines.

    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
    451 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment protocol
    Arm Type
    Other
    Arm Description
    All patients were treated according to the treatment protocol with cast for minimally displaced fractures and surgery for displaced fractures.
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery of distal radius fracture
    Intervention Description
    Surgery of distal radius fracture for displaced fractures
    Intervention Type
    Procedure
    Intervention Name(s)
    Reduction and cast treatment of distal radius fracture
    Intervention Description
    Reduction and cast treatment of distal radius fracture for minimally displaced fractures
    Primary Outcome Measure Information:
    Title
    quickDASH
    Description
    The DASH is a 30-item PROM questionnaire that evaluates the upper extremity [115]. The qDASH is a shortened version with 11 questions that can be used instead of the full 30-item questionnaire [114]. Both are validated for use in upper extremity disorders [114,115]. Neither is specific for wrist function and both yield scores from 0 to 100, where lower scores indicate a better outcome.
    Time Frame
    12 months
    Title
    Range of motion
    Description
    The active ROM of the radiocarpal joint and the radioulnar joints were measured in both hands using a standard goniometer. The arcs of flexion-extension, pronation-supination and radial-ulnar deviation were recorded. Total ROM was calculated as the sum of these three arcs. The loss of ROM in the fractured wrist was expressed in angular degrees compared to the contralateral uninjured wrist [126]. Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.
    Time Frame
    12 months
    Title
    Grip strength
    Description
    Grip strength was measured in a sitting position with the elbow in 90° of flexion, neutral rotation and wrist 0°-30° extension using a JAMAR dynamometer [122]. To prevent it from falling, the examiner may support the JAMAR dynamometer. Both hands are examined, starting with the uninjured hand. Three strength tests were conducted during the assessment of grip strength, with the mean score of the three tests recorded for analysis. Grip strength was adjusted by 10% for the non-dominant hand [123]. The contralateral wrist was used as an internal control. Grip strength was expressed as a percentage (the ratio to the uninjured wrist) and the absolute loss in kilograms comparing the fractured wrist to the uninjured wrist. Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna. Exclusion Criteria: Dementia Previous fracture to the ipsilateral wrist Open fracture Other concomitant or existing damage or injury to the wrist Galeazzi fracture Rheumatoid arthritis Alcohol or drug abuse Neurologic impairment

    12. IPD Sharing Statement

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    Radiological vs Clinical Outcome in DRF

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