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

Last updated: October 3, 2022
Sponsor: Goorens Chul Ki
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05015556
109
  • Ages 16-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Stable distal radial fractures (volar tilt <10° dorsal tilt, <2mm impaction, <2mmarticular depression)
  • 18 - 65 years, professional active

Exclusion

Exclusion Criteria:

  • associated lesions, open fractures, unstable, displaced fractures
  • neurological disorder affecting the upper limb, history of wrist lesion involving thesame wrist, dementia, substance abuse, severe psychiatric disorder and previousinjured contralateral wrist

Study Design

Total Participants: 90
Study Start date:
September 01, 2022
Estimated Completion Date:
December 31, 2023

Study 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

Connect with a study center

  • Department of orthopaedics RZ Tienen

    Tienen, 3300
    Belgium

    Active - Recruiting

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