Clinical trial NCT05015556: Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
Official title: Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radius Fracture Distal
Keywords: Minimal invasive
Osteosynthesis
Conservative treatment
Cost effectiveness
Lead sponsor: Regionaal Ziekenhuis Heilig Hart Tienen
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: QALY
timeFrame: 1 year
measure: Costs
timeFrame: 1 year
Secondary outcomes:
measure: Wrist ROM
timeFrame: 1 year
measure: Grip Strength
timeFrame: 1 year
measure: VAS
timeFrame: 1 year
measure: DASH
timeFrame: 1 year
measure: PRWE
timeFrame: 1 year
Other outcomes:
Locations:
city: Tienen
country: Belgium
facility: Department of orthopaedics RZ Tienen
Study officials:
affiliation: RZ Tienen
name: Lieselot Brepoels, MD
role: STUDY_DIRECTOR
References: