Nondisplaced distal radial fractures are nowadays treated by plaster cast immobilization. In this study, the investigators challenge this classical standard treatment with a surgical solution: minimal invasive volar plating with pronatus quadratus sparing approach. Potential benefits of this surgical treatment are higher cost effectiveness, economical benefit, earlier recuperation of professional and recreational activities, earlier functional recuperation by faster clinical recovery (range of motion, grip strength) and decreased risk of secondary fracture displacement. Potential drawbacks are surgical risks and complications.
Randomized controlled trial Number still to be determined by power analysis on economical outcome measurement Similar study number = 90 Randomization by computer. RZ Tienen, Dr Goorens Level 4 hand surgeon Inclusion criteria: * Stable distal radial fractures (volar tilt \<10° dorsal tilt, \<2mm impaction, \<2mm articular depression) * 18 - 65 years, professional active Exclusion criteria: * associated lesions, open fractures, unstable, displaced fractures * neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist Treatment 1. Cast treatment: 6 weeks with 1 plaster exchange of after 2 weeks 2. Minimal invasive plating: no cast Followup 2 weeks, 6 weeks, 3 months, 6 months, 1 year Primary PROM: * Cost effectiveness: QALY SF-36 * Direct costs: surgery, hospitalisation, follow-up consultations, imaging, medication, wound care, nurse cost, physiotherapy cost * Indirect costs: loss of productivity (SF-HLQ) * Health insurances costs * Confounding factors * Independent vs servant * Insurance? * Work type? * Age, sex, dominance * Work absence, professional recuperation * Recreational sport resumption Secondary PROM * ROM (F/E/RD/UD/P/S) * Grip strength (Jamar) * Pain (VAS) * DASH scare, PRWE score * Satisfaction (VAS), would you do it again? * RX ulna variance, radial tilt * complications
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Muscle sparing osteosynthesis, no casting postoperatively
Department of orthopaedics RZ Tienen
Tienen, Belgium
RECRUITINGQALY
Using the Short Form 36 (SF-36) assessment - cost effectiveness (The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.)
Time frame: 1 year
Costs
Direct, indirect, health insurances
Time frame: 1 year
Wrist ROM
Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination)
Time frame: 1 year
Grip Strength
Using the Jamar grip dynamometer
Time frame: 1 year
VAS
Pain using the VAS (0-10)
Time frame: 1 year
DASH
Disabilities of the arm, shoulder and hand (0-100, lower score means better outcome)
Time frame: 1 year
PRWE
Patient rated wrist evaluation (0-100, lower score, means better outcome)
Time frame: 1 year
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