NCT05015556

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Goorens Chul Ki · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Radius Fracture Distal

Interventions

Type	Name	Description
PROCEDURE	Minimal invasive volar plating	Muscle sparing osteosynthesis, no casting postoperatively

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-08-20
• Last updated: 2022-10-05

Locations

1 site across 1 country: Belgium