Radius FracturesNCT00989222
Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?
A study testing closed reduction and external fixation and Internal fixation with a volar locked plate in people with Radius Fractures, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Radius Fractures
- What is being tested?
- closed reduction and external fixation and Internal fixation with a volar locked plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2006to Jun 2009
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND
- Patient aged 20-70 years with no previous fracture of either wrist.
Who cannot join
- Bilateral fractures,
- Other current injury to the upper extremities,
- Dementia, OR
- Severe comminution or too small distal fragment to allow plating.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital
Stockholm, S-18288
About this study
Official title: Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study
Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.
- Conditions
- Radius Fractures
- Being tested
- closed reduction and external fixation, Internal fixation with a volar locked plate
- Keywords
- Distal radius fractures, Fractures of the distal radius, Volar plate, External fixation
- Medical subject headings
- Radius Fractures, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed reduction and external fixationProcedure or surgery
Also called External fixation: Hoffman compact
Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation
Internal fixation with a volar locked plateProcedure or surgery
Also called Volar locked plate brand: Königsee by Swemac
Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate
| Study group | Role | What they receive |
|---|---|---|
| Volar locked plate | Other | Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate Receives: Procedure: Internal fixation with a volar locked plate |
| External fixation | Other | Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation Receives: Procedure: closed reduction and external fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRWE (patient rated wrist evaluation) score
Measured: 3,6 and 12 months
Secondary outcomes (1)
Objective function (range of movement and grip strength)
Measured: 3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startJan 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gustaf Neander, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989222
- Sponsor's protocol ID
- 2005/4:8
- Status last verified
- Oct 2009
- First submitted
- 2 Oct 2009
- Last updated
- 5 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00989222
- Acronym / sponsor ID
- 2005/4:8
- Conditions
- Radius Fractures
- Keywords
- Distal radius fractures, Fractures of the distal radius, Volar plate, External fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Oct 2009 (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.
Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volar locked plate | Other | Procedure: Internal fixation with a volar locked plateOpen reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate |
| External fixation | Other | Procedure: closed reduction and external fixationFixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND
- Patient aged 20-70 years with no previous fracture of either wrist.
Key exclusion criteria (4 listed)
- Bilateral fractures,
- Other current injury to the upper extremities,
- Dementia, OR
- Severe comminution or too small distal fragment to allow plating.
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 |
|---|---|---|
| closed reduction and external fixationAlso: External fixation: Hoffman compactFixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation | Procedure or surgery | External fixation |
| Internal fixation with a volar locked plateAlso: Volar locked plate brand: Königsee by SwemacOpen reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate | Procedure or surgery | Volar locked plate |
Primary outcome
PRWE (patient rated wrist evaluation) score
Time frame: 3,6 and 12 months
1 secondary outcome
Objective function (range of movement and grip strength)
Time frame: 3,6 and 12 months
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 5 Oct 2009.
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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.
Gustaf Neander, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed reduction and external fixation and Internal fixation with a volar locked plate in people with Radius Fractures, run by Danderyd Hospital at 1 site in Sweden.
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 4 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 5 Oct 2009. 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 Sweden. 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?
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?
PRWE (patient rated wrist evaluation) score (time frame: 3,6 and 12 months). 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 2009.