Articular Displaced Fractures of the Lower End of the RadiusNCT00330122
Restoration of the Radial Length in Compound Wrist Fractures Using Anterior Locking Plates
A study testing fore locked plate and external radiocarpal fixer in people with Articular Displaced Fractures of the Lower End of the Radius, run by University Hospital, Angers at 3 sites in France.
Trial summary
The fractures of the wrist, affecting the distal end of the radius are frequent, in particular in the old subject and/or osteoporotic. Beside the simple fractures treated by mini-invasive surgical methods, there is a considerable number of strong comminuted fractures for which no method of osteosynthesis proves… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Articular Displaced Fractures of the Lower End of the Radius
- What is being tested?
- fore locked plate and external radiocarpal fixer
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2006to May 2006
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- articular displaced fractures of the lower end of the radius with strong metaphysar comminution (groups M3 and M4 of the classification MEC) with an important shortening of the radius, measured by a radio-ulnar index higher than 4 mm compared to the opposite side
- age < 40 years
- autonomous and active
- able to give an assent for the participation in a clinical study
Who cannot join
- articular explosions type E4
Trial locations and contacts
3 sites in 1 country.
Philippe MASSIN, Professor contact
France3 sites, 3 recruiting
- Recruiting
UH of Angers
Angers, 49033
Philippe MASSIN, Professor, phmassin@chu-angers.fr
Philippe MASSIN, Professor
- Recruiting
UH of Besancon
Besançon, 25000
Laurent OBERT, MD, lobert@chu-besancon.fr
Laurent OBERT, MD
- Recruiting
UH of Tours
Tours, 37000
Jacky LAULAN, MD, j.laulan@chu-tours.fr
Jacky LAULAN, MD
About this study
The fractures of the wrist, affecting the distal end of the radius are frequent, in particular in the old subject and/or osteoporotic. Beside the simple fractures treated by mini-invasive surgical methods, there is a considerable number of strong comminuted fractures for which no method of osteosynthesis proves completely satisfactory, especially on osteoporotic bone. However, the restitution of the anatomy remains the principal concern of the surgeon eager to ensure a good functional result to its patient, with the proviso that the least aggressive possible method is used.
Until now, it is of use to rather largely use the external fixer bridging the radiocarpal articulation to maintain the length of the radius, more or less associated with an another method of internal osteosynthesis with minima. The major disadvantage of this kind of assembly is the high rate of neuroalgodystrophic syndromes of the wrist and losses of reduction, sometimes generators of painful after-effects and serious stiffening. These after-effects which are sometimes definitive can be very disabling when they occur among active people, a fortiori when they touch the dominant side.
Read more
The recent alternative to the use of the external fixer is the use of the plates with locking screws, affixed on the foreface of the radius, maintaining the length of the radius but not bridging the articulation. Thus, this kind of osteosynthesis does not generate ligamentary distraction nor of the radiocarpal capsule, factors which would be prevalent in the release of the algodystrophy and of the stiffening. On the other hand, this method of osteosynthesis is more invasive than the installation of an external fixer, because it requires the access of the foreface of the radius and cannot be practised in a percutaneous way. At present, there is any randomized comparative study, the published studies being only comparative retrospective and not controlled, carried out on nonhomogeneous series of fractures.
The principal objective of our study is to evaluate the interest of the locking plates in the maintenance of the radial length in the comminuted fractures of the distal end of the radius.
It is about a prospective, multicentric, randomized study in 2 parallel groups carried out patients from 40 to 80 years hospitalized in a service of Osseous Surgery.
Patients: articular displaced fractures of the lower end of the radius with strong metaphysar comminution (groups M3 and M4 of the classification MEC) with an important shortening of the radius, measured by a radio-ulnar index higher than 4 mm compared to the opposite side. Are excluded the articular explosions type E4. The patients of more than 40 years, autonomous and active, able to give an assent for the participation in a clinical study are included.
Treatment. The first group of patients would be treated by fore locked plate possibly associated with pins. The immobilization would be limited to a antibrachiopalmar splint for 45 days. If, peroperatively, a sufficient stability of the fracture cannot be obtained by the plate alone, and that a complementary stabilization by fixer proves to be necessary, then the case will be entered like a failure of stabilization by locked plate.
The second group of patients would be treated by external radiocarpal fixer in neutralization possibly associated with an internal osteosynthesis with minima (percutaneous pins). The fixer would be left in place during 45 days.
The reeducation would consist in the 2 groups of an active mobilization of the fingers at the beginning, then of an active reeducation of the wrist in flexion/extension and pronosupination starting from the 45th day.
About fifty patients should be included in each group, with a collection of the clinical and radiographic results at 21 days, 45 days, 3 months and 6 months.
- Being tested
- fore locked plate, external radiocarpal fixer
- Keywords
- radius articular displaced fractures, fore locked plate, external radiocarpal fixer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fore locked plateProcedure or surgery
external radiocarpal fixerProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
maintenance of the radial length 3 month after surgery
Secondary outcomes (2)
maintenance of the radial length 6 month after surgery
complication and algodystrophia after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startMar 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Displaced Fractures of the Lower End of the RadiusStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 120 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, France
- Investigators
- Philippe MASSIN, Professor, Study director, UH of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330122
- Sponsor's protocol ID
- PHRC-05-01
- Other IDs
- 2005/20 (CCPPRB), 2006/0017 (DGS)
- Status last verified
- May 2006
- First submitted
- 24 May 2006
- Last updated
- 25 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of the Radial Length in Compound Wrist Fractures Using Anterior Locking Plates
- ClinicalTrials.gov ID
- NCT00330122
- Acronym / sponsor ID
- PHRC-05-01
- Keywords
- radius articular displaced fractures, fore locked plate, external radiocarpal fixer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2006
- Study completion
- May 2006
- First posted
- 25 May 2006 (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 fractures of the wrist, affecting the distal end of the radius are frequent, in particular in the old subject and/or osteoporotic. Beside the simple fractures treated by mini-invasive surgical methods, there is a considerable number of strong comminuted fractures for which no method of osteosynthesis proves completely satisfactory, especially on osteoporotic bone. However, the restitution of the anatomy remains the principal concern of the surgeon eager to ensure a good functional result to its patient, with the proviso that the least aggressive possible method is used.
Until now, it is of use to rather largely use the external fixer bridging the radiocarpal articulation to maintain the length of the radius, more or less associated with an another method of internal osteosynthesis with minima. The major disadvantage of this kind of assembly is the high rate of neuroalgodystrophic syndromes of the wrist and losses of reduction, sometimes generators of painful after-effects and serious stiffening. These after-effects which are sometimes definitive can be very disabling when they occur among active people, a fortiori when they touch the dominant side.
The recent alternative to the use of the external fixer is the use of the plates with locking screws, affixed on the foreface of the radius, maintaining the length of the radius but not bridging the articulation. Thus, this kind of osteosynthesis does not generate ligamentary distraction nor of the radiocarpal capsule, factors which would be prevalent in the release of the algodystrophy and of the stiffening. On the other hand, this method of osteosynthesis is more invasive than the installation of an external fixer, because it requires the access of the foreface of the radius and cannot be practised in a percutaneous way. At present, there is any randomized comparative study, the published studies being only comparative retrospective and not controlled, carried out on nonhomogeneous series of fractures.
The principal objective of our study is to evaluate the interest of the locking plates in the maintenance of the radial length in the comminuted fractures of the distal end of the radius.
It is about a prospective, multicentric, randomized study in 2 parallel groups carried out patients from 40 to 80 years hospitalized in a service of Osseous Surgery.
Patients: articular displaced fractures of the lower end of the radius with strong metaphysar comminution (groups M3 and M4 of the classification MEC) with an important shortening of the radius, measured by a radio-ulnar index higher than 4 mm compared to the opposite side. Are excluded the articular explosions type E4. The patients of more than 40 years, autonomous and active, able to give an assent for the participation in a clinical study are included.
Treatment. The first group of patients would be treated by fore locked plate possibly associated with pins. The immobilization would be limited to a antibrachiopalmar splint for 45 days. If, peroperatively, a sufficient stability of the fracture cannot be obtained by the plate alone, and that a complementary stabilization by fixer proves to be necessary, then the case will be entered like a failure of stabilization by locked plate.
The second group of patients would be treated by external radiocarpal fixer in neutralization possibly associated with an internal osteosynthesis with minima (percutaneous pins). The fixer would be left in place during 45 days.
The reeducation would consist in the 2 groups of an active mobilization of the fingers at the beginning, then of an active reeducation of the wrist in flexion/extension and pronosupination starting from the 45th day.
About fifty patients should be included in each group, with a collection of the clinical and radiographic results at 21 days, 45 days, 3 months and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- articular displaced fractures of the lower end of the radius with strong metaphysar comminution (groups M3 and M4 of the classification MEC) with an important shortening of the radius, measured by a radio-ulnar index higher than 4 mm compared to the opposite side
- age < 40 years
- autonomous and active
- able to give an assent for the participation in a clinical study
Key exclusion criteria (1 listed)
- articular explosions type E4
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 |
|---|---|---|
| fore locked plate | Procedure or surgery | – |
| external radiocarpal fixer | Procedure or surgery | – |
Primary outcome
maintenance of the radial length 3 month after surgery
2 secondary outcomes
maintenance of the radial length 6 month after surgery
complication and algodystrophia after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2006.
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.
Philippe MASSIN, Professor contact
Philippe MASSIN, Professor study director
UH of Angers
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fore locked plate and external radiocarpal fixer in people with Articular Displaced Fractures of the Lower End of the Radius, run by University Hospital, Angers at 3 sites 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe MASSIN, Professor (phmassin@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maintenance of the radial length 3 month after surgery. 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 25 May 2006.