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
About this trial
This is an interventional treatment trial for Distal Radius Fracture
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
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
NCT ID
NCT05558306
First Posted
September 21, 2022
Last Updated
September 23, 2022
Sponsor
Sundsvall Hospital
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
Learn more about this trial
Radiological vs Clinical Outcome in DRF
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