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Surgical Plate Osteosynthesis of Distal Radius Fractures

NCT ID: NCT00205998

Last Updated: 2007-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2005-12-31

Brief Summary

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Primary objective of the study is to demonstrate specific indications for the

surgical treatment of distal radius fractures using the locking compression

plate.

Detailed Description

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In addition the differences between the surgical treatment compared to

conservative treatment with respect to fracture healing, functional outcome

and subject satisfaction will be analysed after 6w./6m./1y./2y.

Conditions

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Distal Radius Fractures

Keywords

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Locking Compression Plate Conservative treatment Surgical treatment Radius fractures AO 23

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Locking Compression Plate 2,4mm

Intervention Type DEVICE

Locking Compression Plate 3,5mm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* skeletally mature female and male
* Distal radius and ulnar fractures AO 23
* 10 days after injury

Exclusion Criteria

* general or local conditions adversely affecting the bone physiology
* ISS \>16
* osteosynthesis close to the wrist joint where a different implant has been used
* history of drug and alcohol abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synthes Inc.

INDUSTRY

Sponsor Role collaborator

AO Hand Expert Group

OTHER

Sponsor Role collaborator

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Principal Investigators

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Andreas W Wentzensen, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

BG-Unfallklinik Ludwigshafen

Jesse B Jupiter, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Peter G De Boer, F.R.C.S.

Role: PRINCIPAL_INVESTIGATOR

York District Hospital

Locations

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Harvard Medical School

Boston, Massachusetts, United States

Site Status

BG-Unfallklinik Ludwigshafen

Ludwigshafen, , Germany

Site Status

York District Hospital

York, , United Kingdom

Site Status

Countries

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United States Germany United Kingdom

Other Identifiers

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01-LCP2,4/3,5-03

Identifier Type: -

Identifier Source: org_study_id