Distal Radius FracturesDRFNCT02990052
Conservative Treatment vs. Volar Plating of Distal Radius Fractures
A study testing Volar plating and Conservative treatment in people with Distal Radius Fractures, run by University of Oulu.
Trial summary
A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Volar plating and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jan 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 50 years-old
- primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)
- primary reduction of fracture is acceptable considering primary conservative treatment
Who cannot join
- bilateral and open fractures and fractures with neurovascular compromise
- other major concurrent fracture necessitating treatment of any kind
- patients under 50 years of age
- previous ipsilateral distal radius fracture
- inflammatory joint disease
- significant radiocarpal-joint degeneration
- patient's bad co-operation or major co-morbidity making an operation contraindicated
About this study
Official title: Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial
A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture
Read the detailed description
Volar plating has became as a standard approach for treating unstable distal radius fractures. The incidence of surgically treated patients with distal radius fractures has increased many fold from the beginning of this millennium, owing mostly to increased number of volar platings. The most striking increase of plate fixations has occurred in older patient groups, especially in females. With volar fixed-angle plate, very near-anatomic, stable fixation with relatively low complication rate, can be achieved even in osteoporotic bone. There are only few randomized, prospective studies comparing results of volar plating and conservative treatment, comparing patients aged over 65 years. Quite little is known of the results comparing conservative treatment and volar plating in patients aged below 65 years.
Main goal of our study was to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture in patients aged over 50 years an older.
- Conditions
- Distal Radius Fractures
- Being tested
- Volar plating, Conservative treatment
- 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 platingProcedure or surgery
Open reduction and volar fixed-angle plate fixation of distal radius fracture
Conservative treatmentProcedure or surgery
Closed reduction \& casting of distal radius fracture
| Study group | Role | What they receive |
|---|---|---|
| Volar plating | Active comparator | Volar fixed-angle plating for dislocated distal radius fracture after closed reduction. Receives: Procedure: Volar plating |
| Conservative treatment | Active comparator | Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture. Receives: Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of DASH-score between two study groups
Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity
Measured: 2 year observation
Secondary outcomes (1)
Difference of radiological parameters between two study groups
Dorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint
Measured: 2 year observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startNov 2008
- Primary completionJan 2014
- Study completionJan 2016
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.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990052
- Sponsor's protocol ID
- Distal Radius Fr. Sirniö
- Acronym
- DRF
- Status last verified
- Dec 2016
- First submitted
- 7 Nov 2016
- Last updated
- 12 Dec 2016
- 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 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02990052
- Acronym / sponsor ID
- DRF / Distal Radius Fr. Sirniö
- Conditions
- Distal Radius Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Dec 2016 (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.
A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture
Detailed description
Volar plating has became as a standard approach for treating unstable distal radius fractures. The incidence of surgically treated patients with distal radius fractures has increased many fold from the beginning of this millennium, owing mostly to increased number of volar platings. The most striking increase of plate fixations has occurred in older patient groups, especially in females. With volar fixed-angle plate, very near-anatomic, stable fixation with relatively low complication rate, can be achieved even in osteoporotic bone. There are only few randomized, prospective studies comparing results of volar plating and conservative treatment, comparing patients aged over 65 years. Quite little is known of the results comparing conservative treatment and volar plating in patients aged below 65 years.
Main goal of our study was to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture in patients aged over 50 years an older.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volar plating | Active comparator | Procedure: Volar platingVolar fixed-angle plating for dislocated distal radius fracture after closed reduction. |
| Conservative treatment | Active comparator | Procedure: Conservative treatmentPrimary conservative treatment (closed reduction and casting) for dislocated distal radius fracture. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 50 years-old
- primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)
- primary reduction of fracture is acceptable considering primary conservative treatment
Key exclusion criteria (7 listed)
- bilateral and open fractures and fractures with neurovascular compromise
- other major concurrent fracture necessitating treatment of any kind
- patients under 50 years of age
- previous ipsilateral distal radius fracture
- inflammatory joint disease
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 platingOpen reduction and volar fixed-angle plate fixation of distal radius fracture | Procedure or surgery | Volar plating |
| Conservative treatmentClosed reduction \& casting of distal radius fracture | Procedure or surgery | Conservative treatment |
Primary outcome
Difference of DASH-score between two study groups
Time frame: 2 year observation
Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity
1 secondary outcome
Difference of radiological parameters between two study groups
Time frame: 2 year observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Volar plating and Conservative treatment in people with Distal Radius Fractures, run by University of Oulu.
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 7 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: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference of DASH-score between two study groups (time frame: 2 year observation). 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 12 Dec 2016.