Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.

Study Overview
=================
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 Cast treatment: 6 weeks with 1 plaster exchange of after 2 weeks 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

Official Title
-----------------
Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.

Conditions
-----------------
Radius Fracture Distal

Intervention / Treatment
-----------------
* Procedure: Minimal invasive volar plating


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Casting<br>Casting of the distal radius for 6 weeks | |
| Active Comparator: Minimal invasive volar plating<br>Muscle sparing osteosynthesis, no casting postoperatively | Procedure: Minimal invasive volar plating<br>* Muscle sparing osteosynthesis, no casting postoperatively<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QALY | 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.) | 1 year | 
| Costs | Direct, indirect, health insurances | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrist ROM | Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination) | 1 year | 
| Grip Strength | Using the Jamar grip dynamometer | 1 year | 
| VAS | Pain using the VAS (0-10) | 1 year | 
| DASH | Disabilities of the arm, shoulder and hand (0-100, lower score means better outcome) | 1 year | 
| PRWE | Patient rated wrist evaluation (0-100, lower score, means better outcome) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimal invasive, Osteosynthesis, Conservative treatment, Cost effectiveness