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

Primary Purpose

Radius Fracture Distal

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Minimal invasive volar plating
Sponsored by
Goorens Chul Ki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fracture Distal focused on measuring Minimal invasive, Osteosynthesis, Conservative treatment, Cost effectiveness

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Department of orthopaedics RZ TienenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Casting

Minimal invasive volar plating

Arm Description

Casting of the distal radius for 6 weeks

Muscle sparing osteosynthesis, no casting postoperatively

Outcomes

Primary Outcome Measures

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.)
Costs
Direct, indirect, health insurances

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2021
Last Updated
October 3, 2022
Sponsor
Goorens Chul Ki
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1. Study Identification

Unique Protocol Identification Number
NCT05015556
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Goorens Chul Ki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Cast treatment: 6 weeks with 1 plaster exchange of after 2 weeks 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture Distal
Keywords
Minimal invasive, Osteosynthesis, Conservative treatment, Cost effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blinding of results by computer of the outcome results. Blinding of the patients or the care provider is not possible due to the obvious differences.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Casting
Arm Type
No Intervention
Arm Description
Casting of the distal radius for 6 weeks
Arm Title
Minimal invasive volar plating
Arm Type
Active Comparator
Arm Description
Muscle sparing osteosynthesis, no casting postoperatively
Intervention Type
Procedure
Intervention Name(s)
Minimal invasive volar plating
Intervention Description
Muscle sparing osteosynthesis, no casting postoperatively
Primary Outcome Measure Information:
Title
QALY
Description
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.)
Time Frame
1 year
Title
Costs
Description
Direct, indirect, health insurances
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Wrist ROM
Description
Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination)
Time Frame
1 year
Title
Grip Strength
Description
Using the Jamar grip dynamometer
Time Frame
1 year
Title
VAS
Description
Pain using the VAS (0-10)
Time Frame
1 year
Title
DASH
Description
Disabilities of the arm, shoulder and hand (0-100, lower score means better outcome)
Time Frame
1 year
Title
PRWE
Description
Patient rated wrist evaluation (0-100, lower score, means better outcome)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chul ki goorens, MD
Phone
0032478907124
Email
cgoorens@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieselot Brepoels, MD
Organizational Affiliation
RZ Tienen
Official's Role
Study Director
Facility Information:
Facility Name
Department of orthopaedics RZ Tienen
City
Tienen
ZIP/Postal Code
3300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chul ki goorens, md
First Name & Middle Initial & Last Name & Degree
chul ki goorens, md
First Name & Middle Initial & Last Name & Degree
niels debaenst, md

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
clinical and economical data

Learn more about this trial

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

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