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

Primary Purpose

Articular Displaced Fractures of the Lower End of the Radius

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fore locked plate
external radiocarpal fixer
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Articular Displaced Fractures of the Lower End of the Radius focused on measuring radius articular displaced fractures, fore locked plate, external radiocarpal fixer

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: articular explosions type E4

Sites / Locations

  • UH of AngersRecruiting
  • UH of BesanconRecruiting
  • UH of ToursRecruiting

Outcomes

Primary Outcome Measures

maintenance of the radial length 3 month after surgery

Secondary Outcome Measures

maintenance of the radial length 6 month after surgery
complication and algodystrophia after surgery

Full Information

First Posted
May 24, 2006
Last Updated
May 24, 2006
Sponsor
University Hospital, Angers
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00330122
Brief Title
Restoration of the Radial Length in Compound Wrist Fractures Using Anterior Locking Plates
Official Title
Restoration of the Radial Length in Compound Wrist Fractures Using Anterior Locking Plates
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Angers
Collaborators
Ministry of Health, France

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Displaced Fractures of the Lower End of the Radius
Keywords
radius articular displaced fractures, fore locked plate, external radiocarpal fixer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
fore locked plate
Intervention Type
Procedure
Intervention Name(s)
external radiocarpal fixer
Primary Outcome Measure Information:
Title
maintenance of the radial length 3 month after surgery
Secondary Outcome Measure Information:
Title
maintenance of the radial length 6 month after surgery
Title
complication and algodystrophia after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: articular explosions type E4
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe MASSIN, Professor
Email
phmassin@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe MASSIN, Professor
Organizational Affiliation
UH of Angers
Official's Role
Study Director
Facility Information:
Facility Name
UH of Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MASSIN, Professor
Email
phmassin@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Philippe MASSIN, Professor
First Name & Middle Initial & Last Name & Degree
Patrick CRONIER, MD
First Name & Middle Initial & Last Name & Degree
Abdelhafid TAHLA, MD
First Name & Middle Initial & Last Name & Degree
Laurent HUBERT, MD
First Name & Middle Initial & Last Name & Degree
Jean-Louis TOULEMONDE, MD
First Name & Middle Initial & Last Name & Degree
Timothee BUFQUIN, MD
First Name & Middle Initial & Last Name & Degree
David TOURAINE, MD
First Name & Middle Initial & Last Name & Degree
Jean HEIZMANN, MD
Facility Name
UH of Besancon
City
Besancon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent OBERT, MD
Email
lobert@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Laurent OBERT, MD
First Name & Middle Initial & Last Name & Degree
Séverin ROCHET, MD
First Name & Middle Initial & Last Name & Degree
Lucas REHBY, MD
Facility Name
UH of Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacky LAULAN, MD
Email
j.laulan@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Jacky LAULAN, MD
First Name & Middle Initial & Last Name & Degree
Philippe BURDIN, MD
First Name & Middle Initial & Last Name & Degree
Gilles FAIZON, MD
First Name & Middle Initial & Last Name & Degree
Jean BRILLAUET, MD
First Name & Middle Initial & Last Name & Degree
Christophe LE DU, MD
First Name & Middle Initial & Last Name & Degree
Frederik DAMIE, MD
First Name & Middle Initial & Last Name & Degree
Praticl COIPEAU, MD
First Name & Middle Initial & Last Name & Degree
Julien ALEXANDRE, MD

12. IPD Sharing Statement

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

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