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

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.

Study Overview

• Status: Recruiting
• Conditions: Radius Fracture Distal
• Intervention / Treatment: Procedure: Minimal invasive volar plating

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

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: chul ki goorens, MD; Phone Number: 0032478907124; Email: cgoorens@msn.com

Study Locations

• Belgium
  • Tienen, Belgium, 3300
    • Recruiting
    • Department of orthopaedics RZ Tienen
    • Contact: chul ki goorens, md
    • Principal Investigator: chul ki goorens, md
    • Sub-Investigator: niels debaenst, md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Casting; Casting of the distal radius for 6 weeks
Active Comparator: Minimal invasive volar plating; Muscle sparing osteosynthesis, no casting postoperatively	Procedure: Minimal invasive volar plating; Muscle sparing osteosynthesis, no casting postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QALY	Using the Short Form 36 (SF-36) assessment - cost effectiveness (The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.)	1 year
Costs	Direct, indirect, health insurances	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrist ROM	Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination)	1 year
Grip Strength	Using the Jamar grip dynamometer	1 year
VAS	Pain using the VAS (0-10)	1 year
DASH	Disabilities of the arm, shoulder and hand (0-100, lower score means better outcome)	1 year
PRWE	Patient rated wrist evaluation (0-100, lower score, means better outcome)	1 year

Collaborators and Investigators

• Sponsor: Goorens Chul Ki
• Investigators: Study Director: Lieselot Brepoels, MD, RZ Tienen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Conservative treatment; Cost effectiveness; Minimal invasive; Osteosynthesis
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: clinical and economical data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No