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

Goorens Chul Ki

Status: Enrolling

Conditions: Radius Fracture Distal

Treatments: Procedure: Minimal invasive volar plating

Study type: Interventional

Funder types: Other

Identifiers

NCT05015556

109

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Casting

No Intervention group

Description:

Casting of the distal radius for 6 weeks

Minimal invasive volar plating

Active Comparator group

Description:

Muscle sparing osteosynthesis, no casting postoperatively

Treatment:

Procedure: Minimal invasive volar plating