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Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?

Primary Purpose

Radius Fractures

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

closed reduction and external fixation

Internal fixation with a volar locked plate

Sponsored by

Danderyd Hospital

About this trial

This is an interventional treatment trial for Radius Fractures focused on measuring Distal radius fractures, Fractures of the distal radius, Volar plate, External fixation

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND
Patient aged 20-70 years with no previous fracture of either wrist.

Exclusion Criteria:

Bilateral fractures,
Other current injury to the upper extremities,
Dementia, OR
Severe comminution or too small distal fragment to allow plating.

Sites / Locations

Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Volar locked plate

External fixation

Arm Description

Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate

Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Outcomes

Primary Outcome Measures

PRWE (patient rated wrist evaluation) score

Secondary Outcome Measures

Objective function (range of movement and grip strength)

Full Information

NCT ID

First Posted

October 2, 2009

Last Updated

October 2, 2009

Sponsor

Danderyd Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00989222

Brief Title

Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?

Official Title

Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Danderyd Hospital

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.

6. Conditions and Keywords

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

Radius Fractures

Keywords

Distal radius fractures, Fractures of the distal radius, Volar plate, External fixation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Volar locked plate

Arm Type

Other

Arm Description

Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate

Arm Title

External fixation

Arm Type

Other

Arm Description

Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Intervention Type

Procedure

Intervention Name(s)

closed reduction and external fixation

Other Intervention Name(s)

External fixation: Hoffman compact

Intervention Description

Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Intervention Type

Procedure

Intervention Name(s)

Internal fixation with a volar locked plate

Other Intervention Name(s)

Volar locked plate brand: Königsee by Swemac

Intervention Description

Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate

Primary Outcome Measure Information:

Title

PRWE (patient rated wrist evaluation) score

Time Frame

3,6 and 12 months

Secondary Outcome Measure Information:

Title

Objective function (range of movement and grip strength)

Time Frame

3,6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND Patient aged 20-70 years with no previous fracture of either wrist. Exclusion Criteria: Bilateral fractures, Other current injury to the upper extremities, Dementia, OR Severe comminution or too small distal fragment to allow plating.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gustaf Neander, MD, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

City

Stockholm

ZIP/Postal Code

S-18288

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?

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