Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)NCT01156766
Metaphyseal Distal Radius Fractures
A study testing - locking anterior plate in people with Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2), run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)
- What is being tested?
- - locking anterior plate
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Mar 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
- age 60 years or older
Who cannot join
- open fracture
- fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3
- polytraumatized patient
- fractures older than 15 days
- infection of the operating site
- previous osseous disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.
The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.
Read the detailed description
Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning.
The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.
These clinical facts need of course to be validated.
- Being tested
- - locking anterior plate
- Keywords
- Fracture, Radius, Osteosynthesis, Metaphyseal, Pinning, Locking anterior plate
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- locking anterior plateDevice
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.
The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
- X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)
Measured: preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths
Secondary outcomes (3)
PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)
Measured: 2 weeks, 5 weeks, 3, 6 and 12 months
Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months)
Measured: 5 weeks, 3, 6 and 12 months
Grip and pinch strength (5 weeks, 3, 6 and 12 months)
Measured: 5 weeks, 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 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker SA, Polyclinique du Parc Rambot
- Responsible party
- Sponsor
- Investigators
- Stéphane DESCAMPS, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156766
- Sponsor's protocol ID
- CHU-0077
- Status last verified
- Jun 2013
- First submitted
- 2 Jul 2010
- Last updated
- 12 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT01156766
- Acronym / sponsor ID
- CHU-0077
- Keywords
- Fracture, Radius, Osteosynthesis, Metaphyseal, Pinning, Locking anterior plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Stryker SA, Polyclinique du Parc Rambot
- Study start
- Jun 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Jul 2010 (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.
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.
The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.
Detailed description
Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning.
The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.
These clinical facts need of course to be validated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
- age 60 years or older
Key exclusion criteria (6 listed)
- open fracture
- fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3
- polytraumatized patient
- fractures older than 15 days
- infection of the operating site
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 |
|---|---|---|
| - locking anterior plateThe number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques. The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis. | Device | – |
Primary outcome
- X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)
Time frame: preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths
3 secondary outcomes
PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)
Time frame: 2 weeks, 5 weeks, 3, 6 and 12 months
Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months)
Time frame: 5 weeks, 3, 6 and 12 months
Grip and pinch strength (5 weeks, 3, 6 and 12 months)
Time frame: 5 weeks, 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 12 Jun 2013.
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.
Stéphane DESCAMPS, MD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing - locking anterior plate in people with Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2), run by University Hospital, Clermont-Ferrand 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 2 inclusion and 6 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 Jun 2013. 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?
- X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths) (time frame: preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths). 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 Jun 2013.