Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT05015556
Status:
UNKNOWN
Last Update Posted:
2022-10-05
First Post:
2021-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
Sponsor:
Goorens Chul Ki
Organization:
Study Overview
Official Title:
Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: