Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT05015556
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
Study:
NCT05015556
Study Brief:
Protocol Section:
NCT05015556