The present collaboration study on the treatment of distal radius fractures is aimed to: (i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE (ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with PRWE (iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture (iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of non-operatively and operatively treated distal radius fracture (v) to assess the association between physical activity and the number of wrist movements measured with Axivity accelerometer and functional outcome measured with PROMs of non-operatively and operatively treated distal radius fractures (vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome (vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (EWC) with functional outcome measured with PRWE and PASS
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
291
conservative treatment with 5 weeks cast immobilization
surgery with volar locking plate with modified Henry's volar approach
Viborg Regional Hospital
Viborg, Denmark
Jyväskylä Central Hospital
Jyväskylä, Finland
Pori Central Hospital
Pori, Finland
Tampere University Hospital
Tampere, Finland
Karolinska University Hospital
Stockholm, Sweden
Change over time in Patient Rated Wrist Evaluation (PRWE)
PRWE is the primary outcome measure of wrist pain and disability in the study. The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics.
Time frame: 3 months, 1 year, 2 years
Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire
The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale.
Time frame: 3 months, 1 year, 2 years
Quality of life measured with the 15-D
The 15D is a validated, generic, self-administered instrument for assessing the health related quality of life among adults. It combines the advantages of a preference-based and single index measure on a 0-1 scale.
Time frame: Baseline, 3 months, 1 year, 2 years
Pain measured in Visual Analogue Scale (VAS)
The VAS is derived by health care professional question of pain in scale 0 to 10 in which 0 implies no pain and 10 the worst possible pain.
Time frame: 3 months, 1 year, 2 years
Grip strength measured with a dynamometer
Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in percentage of the uninjured side.
Time frame: 3 months, 1 year
Pain catastrophizing measured with the pain catastrophizing scale (PCS)
The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire. The PCS is designed to measure person's willingness to catastrophize the pain while they are experiencing it. In the questionnaire patients answer questions about how they feel and think when they are in pain and it can be taken while they are not experiencing pain.
Time frame: baseline, 3 months, 1 year, 2 years
Physical activity measured with Axivity accelerometer
Physical activity will be measured in a subgroup of patients in two separate follow-up time points.
Time frame: 3 months, 1 year
Self-assessment
Patient's self-assessment questionnaire will be analyzed to find out which parameters are of most importance for the patient.
Time frame: Baseline, 1 year, 2 years
EWC
Edinbourgh wrist calculator will be used to estimate the propability of loss of reduction during the follow-up.
Time frame: Baseline
Frailty
Clinical Frailty Score
Time frame: Baseline
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