Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
- Conditions
- Radius Fracture Distal
- Interventions
- Procedure: Minimal invasive volar plating
- Registration Number
- NCT05015556
- Lead Sponsor
- Goorens Chul Ki
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Stable distal radial fractures (volar tilt <10° dorsal tilt, <2mm impaction, <2mm articular depression)
- 18 - 65 years, professional active
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Minimal invasive volar plating Minimal invasive volar plating Muscle sparing osteosynthesis, no casting postoperatively
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
VAS 1 year Pain using the VAS (0-10)
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
Trial Locations
- Locations (1)
Department of orthopaedics RZ Tienen
🇧🇪Tienen, Belgium