Fracture of Distal RadiusfradiusNCT00492492
Treatement of Extension Fractures of the Distal Radius
A study testing trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side in people with Fracture of Distal Radius, run by University Hospital, Limoges at 1 site in France.
Trial summary
Treatment of extension fractures of the distal radius : prospective randomized postoperative comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Fracture of Distal Radius
- What is being tested?
- trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to Jul 2008
- 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
- patient who is affiliated to the NHS (National Health Service)
- patient who has officially given his consent
- on over 50 year old patient
- Patient with an extension fracture of the distal radius
- patient who is in no condition to express his consent
Who cannot join
- patient who is under the protection of justice
- Patient with an open fracture
- Patient with an flexion fracture of the distal radius
- Patient with a metastasis localized in the distal radius
- traumatised patient
- patient who is liable not to profit by medical follow-up in Limoges hospital after he has been operated on
Show all 9Show fewer
- A pregnant woman / a parturient / a breast-feeding mother
- patient who is serving a sentence .
- patient sent to hospital without his consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatement of Extension Fractures of the Distal Radius : Prospective Randomized Postoperative Comparison Between Trans-styloid and Intrafical Pinning on the One Side and Volar Fixed-angle Plating on the Other Side.
Treatment of extension fractures of the distal radius : prospective randomized postoperative comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side.
Read the detailed description
Distal radius fractures are more and more numerous. Most of the time, the people concerned are elderly or old with an osteoporotic bone, and an important dorsal metaphysal comminution. The French reference treatment of the extension distal radius fracture, the Kapandji method, turns out to be less and less performing to treat such complicated fractures. At the moment, two points of view are in opposition in France. On the one side, the point of view of those who are in favour of the treatment by intrafocal pinning: they think they will be able to improve their technique if they add a trans-styloid pinning of stabilisation. On the other side, those who are in favour of a treatment using a volar fixed-angle plating.
The purpose of the study is to compare these two types of treatment by using a prospective and randomized analysis.
The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction at tree month.
The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score) at 6 weeks, 3 months and 6 months, as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.
All the patients taken to the emergency ward of Limoges Hospital, and suffering from an extension distal radius fracture (intra or extra articular according to Kapandji classification) will have the possibility to participate in this study, if they want to.
The patients will be X-rayed before and after the operation, they will have an immobilization for 3 weeks. Then the cast will be removed, and new X-rays will be taken. Then the patients will be allowed to perform their daily activities. A new follow-up control will take place 6 week later, it will include a new series X-rays and functional scores. At this point, people will be able to start physiotherapy. New functional scores and X-ray assessments will still be taken 3 and 6 months later.
All the X-rays will be analyzed by an orthopaedist, a radiologist, and by a radiological software.
- Fonctional scores (quickDASH and Herzberg score) at 6 weeks, 3 months and 6 months.
- X-ray assessment after the operation and at 3 weeks, 6 weeks, 3 months and 6 months.
- Conditions
- Fracture of Distal Radius
- Being tested
- trans-styloid and intrafocal pinning on the one side, volar fixed-angle plating on the other side
- Keywords
- radius,, pinning,, fixed-angle plate,, quick-DASH,, HERZBERG-score.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-styloid and intrafocal pinning on the one sideProcedure or surgery
volar fixed-angle plating on the other sideProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| trans-styloid and intrafocal pinning on the one side | Other | trans-styloid and intrafocal pinning on the one side Receives: Procedure: trans-styloid and intrafocal pinning on the one side |
| volar fixed-angle plating on the other side | Other | volar fixed-angle plating on the other side Receives: Procedure: volar fixed-angle plating on the other side |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction.
Measured: 3 months
Secondary outcomes (1)
The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score), as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.
Measured: 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture of Distal RadiusStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis CHARISSOUX, MD, Principal investigator, CHU LIMOGES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492492
- Sponsor's protocol ID
- I06029
- Acronym
- fradius
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2007
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marcheix PS, Dotzis A, Benko PE, Siegler J, Arnaud JP, Charissoux JL. Extension fractures of the distal radius in patients older than 50: a prospective randomized study comparing fixation using mixed pins or a palmar fixed-angle plate. J Hand Surg Eur Vol. 2010 Oct;35(8):646-51. doi: 10.1177/1753193410364179. Epub 2010 Mar 17.
PubMed 20237186
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatement of Extension Fractures of the Distal Radius : Prospective Randomized Postoperative Comparison Between Trans-styloid and Intrafical Pinning on the One Side and Volar Fixed-angle Plating on the Other Side.
- ClinicalTrials.gov ID
- NCT00492492
- Acronym / sponsor ID
- fradius / I06029
- Conditions
- Fracture of Distal Radius
- Keywords
- radius,, pinning,, fixed-angle plate,, quick-DASH,, HERZBERG-score.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Jun 2007 (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.
Treatment of extension fractures of the distal radius : prospective randomized postoperative comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side.
Detailed description
Distal radius fractures are more and more numerous. Most of the time, the people concerned are elderly or old with an osteoporotic bone, and an important dorsal metaphysal comminution. The French reference treatment of the extension distal radius fracture, the Kapandji method, turns out to be less and less performing to treat such complicated fractures. At the moment, two points of view are in opposition in France. On the one side, the point of view of those who are in favour of the treatment by intrafocal pinning: they think they will be able to improve their technique if they add a trans-styloid pinning of stabilisation. On the other side, those who are in favour of a treatment using a volar fixed-angle plating.
The purpose of the study is to compare these two types of treatment by using a prospective and randomized analysis.
The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction at tree month.
The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score) at 6 weeks, 3 months and 6 months, as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.
All the patients taken to the emergency ward of Limoges Hospital, and suffering from an extension distal radius fracture (intra or extra articular according to Kapandji classification) will have the possibility to participate in this study, if they want to.
The patients will be X-rayed before and after the operation, they will have an immobilization for 3 weeks. Then the cast will be removed, and new X-rays will be taken. Then the patients will be allowed to perform their daily activities. A new follow-up control will take place 6 week later, it will include a new series X-rays and functional scores. At this point, people will be able to start physiotherapy. New functional scores and X-ray assessments will still be taken 3 and 6 months later.
All the X-rays will be analyzed by an orthopaedist, a radiologist, and by a radiological software.
- Fonctional scores (quickDASH and Herzberg score) at 6 weeks, 3 months and 6 months.
- X-ray assessment after the operation and at 3 weeks, 6 weeks, 3 months and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trans-styloid and intrafocal pinning on the one side | Other | Procedure: trans-styloid and intrafocal pinning on the one sidetrans-styloid and intrafocal pinning on the one side |
| volar fixed-angle plating on the other side | Other | Procedure: volar fixed-angle plating on the other sidevolar fixed-angle plating on the other side |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient who is affiliated to the NHS (National Health Service)
- patient who has officially given his consent
- on over 50 year old patient
- Patient with an extension fracture of the distal radius
- patient who is in no condition to express his consent
Key exclusion criteria (9 listed)
- patient who is under the protection of justice
- Patient with an open fracture
- Patient with an flexion fracture of the distal radius
- Patient with a metastasis localized in the distal radius
- traumatised 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 |
|---|---|---|
| trans-styloid and intrafocal pinning on the one side | Procedure or surgery | trans-styloid and intrafocal pinning on the one side |
| volar fixed-angle plating on the other side | Procedure or surgery | volar fixed-angle plating on the other side |
Primary outcome
The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction.
Time frame: 3 months
1 secondary outcome
The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score), as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.
Time frame: 6 weeks, 3 months, 6 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 20 Jul 2025.
- Results publication: PubMed 20237186Marcheix PS, Dotzis A, Benko PE, Siegler J, Arnaud JP, Charissoux JL. Extension fractures of the distal radius in patients older than 50: a prospective randomized study comparing fixation using mixed pins or a palmar fixed-angle plate. J Hand Surg Eur Vol. 2010 Oct;35(8):646-51. doi: 10.1177/1753193410364179. Epub 2010 Mar 17.
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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.
Jean-Louis CHARISSOUX, MD principal investigator
CHU LIMOGES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side in people with Fracture of Distal Radius, run by University Hospital, Limoges at 1 site in France.
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 5 inclusion and 9 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 20 Jul 2025. 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 France. 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 main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00492492, which also lists 1 linked publication.
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 20 Jul 2025.