Distal Radius FracturesNCT04716309
Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).
A study testing Open reduction and volar locking plate and closed reduction and K-wires. in people with Distal Radius Fractures and Wrist Fracture, run by Oslo University Hospital at 1 site in Norway.
Trial summary
120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fractures, Wrist Fracture, Colles' Fracture
- What is being tested?
- Open reduction and volar locking plate and closed reduction and K-wires.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 16 Feb 2021to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- distal radius fractures of AO- A2, A3 and C1 which should be operated on in accordance with Norwegian guidelines
- >18 years and <65 years
- address in Oslo municipality
Who cannot join
- multitrauma
- previous fracture same wrist
- multiple injuries on the same side
- not competent to consent
- dementia / nursing home patient
- substance abuse
Show all 14Show fewer
- foreign / tourists
- median nerve compression requiring emergency surgery
- pathological fracture
- open fracture
- congenital malformations that make it difficult to interpret data
- patient does not want surgical treatment
- not operable due to comorbidity (ASA 4, some ASA 3 after assessment by anesthesiologist)
- more than 10 days after injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unstable Distal Radius Fractures AO-type A2, A3 and C1 With Dorsal Dislocation in Patients Aged 18-64 Years. Open Reduction and Volar Locking Plate Versus Closed Reduction and Percutaenous Pinning. A Randomized Controlled Trial.
120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.
- Conditions
- Distal Radius Fractures, Wrist Fracture, Colles' Fracture
- Being tested
- Open reduction and volar locking plate and closed reduction and K-wires.
- Medical subject headings
- Wrist Fractures, Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and volar locking plate and closed reduction and K-wires.Procedure or surgery
DVR Anatomic Plate, K-wires
| Study group | Role | What they receive |
|---|---|---|
| VLP | Active comparator | Open reduction and volar locking plate Receives: Procedure: Open reduction and volar locking plate and closed reduction and K-wires. |
| CRPP | Active comparator | Closed reduction and percutaenous K-wires/pins Receives: Procedure: Open reduction and volar locking plate and closed reduction and K-wires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Related Wrist and Hand Evaluation (PRWHE) score
PROM of 15 questions, score ranging from 0 (best) to 100 (worst)
Measured: 1 year
Secondary outcomes (4)
Quick Dash score
PROM of 11 questions, score ranging from 0 (best) to 100 (worst)
Measured: 1 year
X-ray wrist posterior-anterior and lateral view
Volar tilt (degrees), radial inclination (degrees), ulnar variance (mm), stepp-off (mm)
Measured: 1 year
Range of motion
Flexion, extension, supination and pronation measured in degrees from neutral position, pulpa palm distance in cm
Measured: 1 year
Grip strength
Grip strength with a hand dynamometer
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 Jan 2021
- Study start16 Feb 2021
- Primary completion8 Feb 2024
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sophies Minde Ortopedi
- Responsible party
- Principal investigator, Børge Olsen, Oslo University Hospital
- Investigators
- John Williksen, MD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716309
- Sponsor's protocol ID
- 85724
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unstable Distal Radius Fractures AO-type A2, A3 and C1 With Dorsal Dislocation in Patients Aged 18-64 Years. Open Reduction and Volar Locking Plate Versus Closed Reduction and Percutaenous Pinning. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04716309
- Acronym / sponsor ID
- 85724
- Conditions
- Distal Radius Fractures, Wrist Fracture, Colles' Fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sophies Minde Ortopedi
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Jan 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.
120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLP | Active comparator | Procedure: Open reduction and volar locking plate and closed reduction and K-wires.Open reduction and volar locking plate |
| CRPP | Active comparator | Procedure: Open reduction and volar locking plate and closed reduction and K-wires.Closed reduction and percutaenous K-wires/pins |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- distal radius fractures of AO- A2, A3 and C1 which should be operated on in accordance with Norwegian guidelines
- >18 years and <65 years
- address in Oslo municipality
Key exclusion criteria (14 listed)
- multitrauma
- previous fracture same wrist
- multiple injuries on the same side
- not competent to consent
- dementia / nursing home patient
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 |
|---|---|---|
| Open reduction and volar locking plate and closed reduction and K-wires.DVR Anatomic Plate, K-wires | Procedure or surgery | CRPP, VLP |
Primary outcome
Patient-Related Wrist and Hand Evaluation (PRWHE) score
Time frame: 1 year
PROM of 15 questions, score ranging from 0 (best) to 100 (worst)
4 secondary outcomes
Quick Dash score
Time frame: 1 year
X-ray wrist posterior-anterior and lateral view
Time frame: 1 year
Range of motion
Time frame: 1 year
Grip strength
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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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.
John Williksen, MD study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction and volar locking plate and closed reduction and K-wires. in people with Distal Radius Fractures and Wrist Fracture, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2024. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Related Wrist and Hand Evaluation (PRWHE) score (time frame: 1 year). 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 21 Feb 2024.