Distal Radius FractureDROCNCT02336035
Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?
A study testing Volar plate in people with Distal Radius Fracture, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Volar plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to Sep 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- AO/OTA class A- and C-fractures
- Age > 65 years
- Unacceptable primary reduction or redislocation < 20 days post-injury with at least one of the following findings:
- dorsal angulation > 10 degrees
- radial shortening > 3 mm
- intraarticular step-off > 2 mm
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- Ability to sign an informed consent
- Acute fracture, inclusion within 20 days from injury.
- Ability to reconstruct the articular surface with a volar locking plate
Who cannot join
- Volar angulated fractures and AO type B
- Associated diseases contraindicating surgery
- Mental impairment, nursery home patient
- Earlier wrist injury
- Pathological fractures
- Open fractures (>Gustilo-Anderson I) or damaged soft tissue
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- Drug abuse
- Concomitant injuries that might affect outcome
- Congenital anomaly of affected extremity
- Median nerve compression that requires acute operation
- Foreign language
- Tourists
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unstable Distal Radius Fractures in Patients Over 65 Years. Conservative Treatment With Cast Immobilization Versus Volar Locking Plate. A Prospective Randomized Controlled Trial.
Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.
Read the detailed description
The investigators want to investigate if there is a difference between operative treatment with volar locking plates and cast immobilization in patient above 65 years with unstable distal radius fractures AO/OTA type A and C . Eligible patients that meets the radiological criteria (see inclusion criteria) will be randomized to cast immobilization or operation with volar locking plate.
The investigators are planning a non-inferiority design.
The current study will test the following null hypothesis:
In patients over 65 years of age with unstable distal radius fractures AO/OTA type A and C,volar locking plates are superior to cast immobilization by more than 8 points, as evaluated by quick-DASH at 12 months follow-up.
The investigators will perform a cost-effectiveness analysis comparing QALYs (Quality-adjusted life years) and costs with the two interventions the first year of follow-up.
- Conditions
- Distal Radius Fracture
- Being tested
- Volar plate
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volar plateProcedure or surgery
Also called Volar locking plate, VLP
Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate
| Study group | Role | What they receive |
|---|---|---|
| Cast immobilization | No intervention | Cast immobilization for 5 weeks from primary injury/reduction. Thereafter active exercise within the range of pain. Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years. |
| Operation | Experimental | Operation with a volar plate. Cast immobilization for 2 weeks after operation, thereafter active motion without weight for 4 weeks. 6 weeks after operation the patients are allowed active exercise within the range of pain.
Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years. Receives: Procedure: Volar plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick disabilities of the arm, shoulder and hand; Quick-DASH
Questionnaire
Measured: 1 year
Secondary outcomes (9)
Quick DASH
Questionnaire
Measured: 3 and 6 months; 2 and 5 years
Patient rated wrist evaluation (PRWE)
PRWE, Questionnaire
Measured: 3, 6 and 12 months; 2 and 5 years
Grip strength
score
Measured: 3, 6 and 12 months; 2 and 5 years
Range of motion
score
Measured: 3, 6 and 12 months; 2 and 5 years
Over all satisfaction
Over all satisfaction with hand function, numeric scale 0-10
Measured: 6 weeks; 3, 6 and 12 months; 2 and 5 years
Complications
Registration of complications
Measured: 6 weeks; 3, 6 and 12 months; 2 and 5 years
X-ray, wrist
Radial shortening, dorsal tilt, intraarticular step-off
Measured: 6 weeks; 3 and 12 months; 2 and 5 years
EQ-5d (EuroQol)
Questionnaire
Measured: 6 weeks; 3, 6 and 12 months; 2 and 5 years
Registration of need for assistance in daily life
Registration of need for assistance in daily life to register costs generated
Measured: 6 weeks; 3, 6 and 12 months; 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2018
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sondre Stafsne Hassellund, Oslo University Hospital
- Investigators
- Jan Erik Madsen, Professor, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336035
- Sponsor's protocol ID
- 2014 3830 RCT radius 65
- Acronym
- DROC
- Status last verified
- Sep 2021
- First submitted
- 5 Jan 2015
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unstable Distal Radius Fractures in Patients Over 65 Years. Conservative Treatment With Cast Immobilization Versus Volar Locking Plate. A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02336035
- Acronym / sponsor ID
- DROC / 2014 3830 RCT radius 65
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 12 Jan 2015 (estimated)
- 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.
Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.
Detailed description
The investigators want to investigate if there is a difference between operative treatment with volar locking plates and cast immobilization in patient above 65 years with unstable distal radius fractures AO/OTA type A and C . Eligible patients that meets the radiological criteria (see inclusion criteria) will be randomized to cast immobilization or operation with volar locking plate.
The investigators are planning a non-inferiority design.
The current study will test the following null hypothesis:
In patients over 65 years of age with unstable distal radius fractures AO/OTA type A and C,volar locking plates are superior to cast immobilization by more than 8 points, as evaluated by quick-DASH at 12 months follow-up.
The investigators will perform a cost-effectiveness analysis comparing QALYs (Quality-adjusted life years) and costs with the two interventions the first year of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cast immobilization | No intervention | –Cast immobilization for 5 weeks from primary injury/reduction. Thereafter active exercise within the range of pain. Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years. |
| Operation | Experimental | Procedure: Volar plateOperation with a volar plate. Cast immobilization for 2 weeks after operation, thereafter active motion without weight for 4 weeks. 6 weeks after operation the patients are allowed active exercise within the range of pain. Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- AO/OTA class A- and C-fractures
- Age > 65 years
- Unacceptable primary reduction or redislocation < 20 days post-injury with at least one of the following findings:
- dorsal angulation > 10 degrees
- radial shortening > 3 mm
Key exclusion criteria (12 listed)
- Volar angulated fractures and AO type B
- Associated diseases contraindicating surgery
- Mental impairment, nursery home patient
- Earlier wrist injury
- Pathological fractures
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 |
|---|---|---|
| Volar plateAlso: Volar locking plate, VLPFlexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate | Procedure or surgery | Operation |
Primary outcome
Quick disabilities of the arm, shoulder and hand; Quick-DASH
Time frame: 1 year
Questionnaire
9 secondary outcomes
Quick DASH
Time frame: 3 and 6 months; 2 and 5 years
Patient rated wrist evaluation (PRWE)
Time frame: 3, 6 and 12 months; 2 and 5 years
Grip strength
Time frame: 3, 6 and 12 months; 2 and 5 years
Range of motion
Time frame: 3, 6 and 12 months; 2 and 5 years
Over all satisfaction
Time frame: 6 weeks; 3, 6 and 12 months; 2 and 5 years
Complications
Time frame: 6 weeks; 3, 6 and 12 months; 2 and 5 years
X-ray, wrist
Time frame: 6 weeks; 3 and 12 months; 2 and 5 years
EQ-5d (EuroQol)
Time frame: 6 weeks; 3, 6 and 12 months; 2 and 5 years
Registration of need for assistance in daily life
Time frame: 6 weeks; 3, 6 and 12 months; 2 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Jan Erik Madsen, Professor study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volar plate in people with Distal Radius 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 9 inclusion and 12 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 10 Sep 2021. 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?
Results are not available in the source record.
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?
Quick disabilities of the arm, shoulder and hand; Quick-DASH (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 10 Sep 2021.