Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05015556
Study type	Interventional
Source	Regionaal Ziekenhuis Heilig Hart Tienen
Contact	chul ki goorens, MD
Phone	0032478907124
Email	cgoorens@msn.com
Status	Recruiting
Phase	N/A
Start date	September 1, 2022
Completion date	December 31, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms