Radius Fracture Distal
Conditions
Keywords
Minimal invasive, Osteosynthesis, Conservative treatment, Cost effectiveness
Brief summary
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.
Detailed description
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
Interventions
PROCEDUREMinimal invasive volar plating
Muscle sparing osteosynthesis, no casting postoperatively
Sponsors
Goorens Chul Ki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding of results by computer of the outcome results. Blinding of the patients or the care provider is not possible due to the obvious differences.
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QALY | 1 year | 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.) |
| Costs | 1 year | Direct, indirect, health insurances |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS | 1 year | Pain using the VAS (0-10) |
| Wrist ROM | 1 year | Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination) |
| PRWE | 1 year | Patient rated wrist evaluation (0-100, lower score, means better outcome) |
| DASH | 1 year | Disabilities of the arm, shoulder and hand (0-100, lower score means better outcome) |
| Grip Strength | 1 year | Using the Jamar grip dynamometer |
Countries
Belgium
Contacts
Primary Contactchul ki goorens, MD
Outcome results
None listed