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Metaphyseal Distal Radius Fractures

Primary Purpose

Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

- locking anterior plate

About this trial

This is an interventional treatment trial for Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2) focused on measuring Fracture, Radius, Osteosynthesis, Metaphyseal, Pinning, Locking anterior plate

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
age 60 years or older

Exclusion Criteria:

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

Sites / Locations

CHU Clermont-Ferrand

Outcomes

Primary Outcome Measures

- X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)

Secondary Outcome Measures

PAIN score (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)

Grip and pinch strength (5 weeks, 3, 6 and 12 months)

Full Information

NCT ID

NCT01156766

First Posted

July 2, 2010

Last Updated

June 11, 2013

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Stryker SA, Polyclinique du Parc Rambot

1. Study Identification

Unique Protocol Identification Number

NCT01156766

Brief Title

Metaphyseal Distal Radius Fractures

Official Title

Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Stryker SA, Polyclinique du Parc Rambot

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)

Keywords

Fracture, Radius, Osteosynthesis, Metaphyseal, Pinning, Locking anterior plate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

- locking anterior plate

Intervention Description

Primary Outcome Measure Information:

Title

- 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

Secondary Outcome Measure Information:

Title

PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)

Time Frame

2 weeks, 5 weeks, 3, 6 and 12 months

Title

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

Title

Grip and pinch strength (5 weeks, 3, 6 and 12 months)

Time Frame

5 weeks, 3, 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2) age 60 years or older Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stéphane DESCAMPS, MD

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

12. IPD Sharing Statement

Learn more about this trial

Metaphyseal Distal Radius Fractures

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