Radius Fracture DistalNCT05015556
Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
A study testing Minimal invasive volar plating in people with Radius Fracture Distal, run by Goorens Chul Ki at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Radius Fracture Distal
- What is being tested?
- Minimal invasive volar plating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Stable distal radial fractures (volar tilt <10° dorsal tilt, <2mm impaction, <2mm articular depression)
- 18 - 65 years, professional active
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Department of orthopaedics RZ Tienen
Tienen, 3300
chul ki goorens, md
chul ki goorens, md
About this study
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.
Read the 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
- Conditions
- Radius Fracture Distal
- Being tested
- Minimal invasive volar plating
- Keywords
- Minimal invasive, Osteosynthesis, Conservative treatment, Cost effectiveness
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive volar platingProcedure or surgery
Muscle sparing osteosynthesis, no casting postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Casting | No intervention | Casting of the distal radius for 6 weeks |
| Minimal invasive volar plating | Active comparator | Muscle sparing osteosynthesis, no casting postoperatively Receives: Procedure: Minimal invasive volar plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 1 year
Costs
Direct, indirect, health insurances
Measured: 1 year
Secondary outcomes (5)
Wrist ROM
Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination)
Measured: 1 year
Grip Strength
Using the Jamar grip dynamometer
Measured: 1 year
VAS
Pain using the VAS (0-10)
Measured: 1 year
DASH
Disabilities of the arm, shoulder and hand (0-100, lower score means better outcome)
Measured: 1 year
PRWE
Patient rated wrist evaluation (0-100, lower score, means better outcome)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goorens Chul Ki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Goorens Chul Ki, Regionaal Ziekenhuis Heilig Hart Tienen
- Investigators
- Lieselot Brepoels, MD, Study director, RZ Tienen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015556
- Sponsor's protocol ID
- 109
- Status last verified
- Oct 2022
- First submitted
- 3 Jun 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: clinical and economical data
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
- ClinicalTrials.gov ID
- NCT05015556
- Acronym / sponsor ID
- 109
- Conditions
- Radius Fracture Distal
- Keywords
- Minimal invasive, Osteosynthesis, Conservative treatment, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Goorens Chul KiUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Casting | No intervention | –Casting of the distal radius for 6 weeks |
| Minimal invasive volar plating | Active comparator | Procedure: Minimal invasive volar platingMuscle sparing osteosynthesis, no casting postoperatively |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Stable distal radial fractures (volar tilt <10° dorsal tilt, <2mm impaction, <2mm articular depression)
- 18 - 65 years, professional active
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal invasive volar platingMuscle sparing osteosynthesis, no casting postoperatively | Procedure or surgery | Minimal invasive volar plating |
Primary outcome
QALY
Time frame: 1 year
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
Time frame: 1 year
Direct, indirect, health insurances
5 secondary outcomes
Wrist ROM
Time frame: 1 year
Grip Strength
Time frame: 1 year
VAS
Time frame: 1 year
DASH
Time frame: 1 year
PRWE
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: No. clinical and economical data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieselot Brepoels, MD study director
RZ Tienen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal invasive volar plating in people with Radius Fracture Distal, run by Goorens Chul Ki at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chul ki goorens, MD (0032478907124, cgoorens@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QALY (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.