Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
-
- STATUS
- Recruiting
-
- End date
- Dec 31, 2023
-
- participants needed
- 90
-
- sponsor
- Goorens Chul Ki
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.
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
Details
| Condition | Radius Fracture Distal |
|---|---|
| Treatment | Minimal invasive volar plating |
| Clinical Study Identifier | NCT05015556 |
| Sponsor | Goorens Chul Ki |
| Last Modified on | 21 October 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer