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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

phmassin@chu-angers.fr

France3 sites, 3 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

    Recruiting

Other trials in France

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.

  1. maintenance of the radial length 3 month after surgery

Secondary outcomes (2)
  1. maintenance of the radial length 6 month after surgery

  2. 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.

  1. First posted25 May 2006 (estimated)
  2. Study startMar 2006
  3. Study completionMay 2006

Resources

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
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

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.

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