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
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
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
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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