Dorsally Displaced Intraarticular Distal Radius FracturesNCT01034943
Extraarticular Distal Radius Fractures, X-fix or Volar Fixation
A study testing External fixation and Volar plate in people with Dorsally Displaced Intraarticular Distal Radius Fractures and Age 50 - 74 for Females or 60-74 for Males, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Dorsally Displaced Intraarticular Distal Radius Fractures, Age 50 - 74 for Females or 60-74 for Males, Low Energy Trauma
- What is being tested?
- External fixation and Volar plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2009to Feb 2014
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female 50-74 years or male 60-74 years
- Dorsally displaced extraarticular distal radius fracture
- Dorsal angulation >20 degrees measured from the plane perpendicular to the radius axis
- Low energy trauma
- Injury <72 hours when diagnosed
- Patient independent of help for ADL
Who cannot join
- Earlier dysfunction in any wrist
- Other major injuries
- Rheumatoid arthritis or other systemic joint disease
- Dementia or severe psychiatric disease
- Severe medical condition making general anesthesia a considerable risk
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Stockholm South Hospital Department of Orthopeadic Surgery
Stockholm, Stockholm County, 118 83
About this study
Official title: Dorsally Displaced Extraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial
Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.
Read the detailed description
This study has been merged with study NCT01035359 and a new ethical permission has been granted by the Swedish National Ethic board
- Conditions
- Dorsally Displaced Intraarticular Distal Radius Fractures, Age 50 - 74 for Females or 60-74 for Males, Low Energy Trauma
- Being tested
- External fixation, Volar plate
- Keywords
- radius, fracture, wrist, external, fixation, volar, plate, DASH, PRWE
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External fixationProcedure or surgery
Also called External Fixation with Hoffman external fixator (Stryker)
Operation with external fixation and optional addition of k-wire
Volar plateProcedure or surgery
Also called Synthes volar two column plate (TCP)
Operation with a Synthes volar two column plate (TCP)
| Study group | Role | What they receive |
|---|---|---|
| External fixation | Active comparator | Operation with external fixation and optional addition of k-wire Receives: Procedure: External fixation |
| Volar plate | Active comparator | Operation with Synthes volar two column plate (TCP) Receives: Procedure: Volar plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.
Measured: 12 months
Secondary outcomes (2)
A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist.
Measured: 12 months
A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dorsally Displaced Intraarticular Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sari Ponzer, Karolinska Institutet
- Investigators
- Sari Ponzer, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034943
- Sponsor's protocol ID
- DRF Extra
- Status last verified
- Mar 2014
- First submitted
- 16 Dec 2009
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dorsally Displaced Extraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01034943
- Acronym / sponsor ID
- DRF Extra
- Conditions
- Dorsally Displaced Intraarticular Distal Radius Fractures, Age 50 - 74 for Females or 60-74 for Males, Low Energy Trauma
- Keywords
- radius, fracture, wrist, external, fixation, volar, plate, DASH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 Dec 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.
Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.
Detailed description
This study has been merged with study NCT01035359 and a new ethical permission has been granted by the Swedish National Ethic board
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External fixation | Active comparator | Procedure: External fixationOperation with external fixation and optional addition of k-wire |
| Volar plate | Active comparator | Procedure: Volar plateOperation with Synthes volar two column plate (TCP) |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female 50-74 years or male 60-74 years
- Dorsally displaced extraarticular distal radius fracture
- Dorsal angulation >20 degrees measured from the plane perpendicular to the radius axis
- Low energy trauma
- Injury <72 hours when diagnosed
Key exclusion criteria (5 listed)
- Earlier dysfunction in any wrist
- Other major injuries
- Rheumatoid arthritis or other systemic joint disease
- Dementia or severe psychiatric disease
- Severe medical condition making general anesthesia a considerable risk
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 |
|---|---|---|
| External fixationAlso: External Fixation with Hoffman external fixator (Stryker)Operation with external fixation and optional addition of k-wire | Procedure or surgery | External fixation |
| Volar plateAlso: Synthes volar two column plate (TCP)Operation with a Synthes volar two column plate (TCP) | Procedure or surgery | Volar plate |
Primary outcome
The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.
Time frame: 12 months
2 secondary outcomes
A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist.
Time frame: 12 months
A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument.
Time frame: 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 13 Mar 2014.
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.
Sari Ponzer, Professor 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 External fixation and Volar plate in people with Dorsally Displaced Intraarticular Distal Radius Fractures and Age 50 - 74 for Females or 60-74 for Males, run by Karolinska Institutet 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 6 inclusion and 5 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 13 Mar 2014. 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?
The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb. (time frame: 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 13 Mar 2014.