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Status unknownNCT00330122Updated May 25, 2006

Restoration of the Radial Length in Compound Wrist Fractures Using Anterior Locking Plates

An interventional study of fore locked plate and external radiocarpal fixer in Articular Displaced Fractures of the Lower End of the Radius, sponsored by University Hospital, Angers. Status unknown at 3 sites in France. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2006-05-25.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Articular Displaced Fractures of the Lower End of the Radius

Keywords

  • radius articular displaced fractures
  • fore locked plate
  • external radiocarpal fixer
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 120 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • articular explosions type E4
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants

Interventions

  • Procedurefore locked plate
  • Procedureexternal radiocarpal fixer
06

What researchers measure

Primary outcomes

  1. maintenance of the radial length 3 month after surgery

Secondary outcomes

  1. maintenance of the radial length 6 month after surgery

  2. complication and algodystrophia after surgery

07

Study locations

3 of 3 sites recruiting
  • UH of Angers
    Angers, 49033, France
    • Philippe MASSIN, Professor · Contact · phmassin@chu-angers.fr
    • Philippe MASSIN, Professor · Principal investigator
    • Patrick CRONIER, MD · Sub investigator
    • Abdelhafid TAHLA, MD · Sub investigator
    • Laurent HUBERT, MD · Sub investigator
    • Jean-Louis TOULEMONDE, MD · Sub investigator
    • Timothee BUFQUIN, MD · Sub investigator
    • David TOURAINE, MD · Sub investigator
    • Jean HEIZMANN, MD · Sub investigator
    Recruiting
  • UH of Besancon
    Besancon, 25000, France
    • Laurent OBERT, MD · Contact · lobert@chu-besancon.fr
    • Laurent OBERT, MD · Principal investigator
    • Séverin ROCHET, MD · Sub investigator
    • Lucas REHBY, MD · Sub investigator
    Recruiting
  • UH of Tours
    Tours, 37000, France
    • Jacky LAULAN, MD · Contact · j.laulan@chu-tours.fr
    • Jacky LAULAN, MD · Principal investigator
    • Philippe BURDIN, MD · Sub investigator
    • Gilles FAIZON, MD · Sub investigator
    • Jean BRILLAUET, MD · Sub investigator
    • Christophe LE DU, MD · Sub investigator
    • Frederik DAMIE, MD · Sub investigator
    • Praticl COIPEAU, MD · Sub investigator
    • Julien ALEXANDRE, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00330122
Lead sponsor
University Hospital, Angers
Collaborators
Ministry of Health, France
First posted
May 25, 2006
Start date
Mar 2006
Completion
May 2006
Last update
May 25, 2006

Study contacts

Philippe MASSIN, Professor
Contact
phmassin@chu-angers.fr
Philippe MASSIN, Professor
study director · UH of Angers
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2006. You cannot join it, but the record below documents what was studied.

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