Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2021
CompletedFirst Posted
Study publicly available on registry
August 20, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 5, 2022
October 1, 2022
1.3 years
June 3, 2021
October 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Wrist ROM
1 year
Grip Strength
1 year
VAS
1 year
DASH
1 year
PRWE
1 year
Study Arms (2)
Casting
NO INTERVENTIONCasting of the distal radius for 6 weeks
Minimal invasive volar plating
ACTIVE COMPARATORMuscle sparing osteosynthesis, no casting postoperatively
Interventions
Muscle sparing osteosynthesis, no casting postoperatively
Eligibility Criteria
You may qualify if:
- Stable distal radial fractures (volar tilt \<10° dorsal tilt, \<2mm impaction, \<2mm articular depression)
- years, professional active
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Goorens Chul Kilead
Study Sites (1)
Department of orthopaedics RZ Tienen
Tienen, 3300, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lieselot Brepoels, MD
RZ Tienen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D., Principal Investigator
Study Record Dates
First Submitted
June 3, 2021
First Posted
August 20, 2021
Study Start
September 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
October 5, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
clinical and economical data