Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions

NCT ID: NCT01670344

Last Updated: 2013-06-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-06-30

Brief Summary

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This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.

Aim of the study is the validation and comparison of the innovative medical device with the current standard method.

Detailed Description

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Conditions

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Fracture of Distal End of Radius

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Treatment with investigational method (virtual implant positioning system)

Group Type OTHER

Treatment with investigational method (virtual implant positioning system)

Intervention Type PROCEDURE

B

Treatment with surgical standard of care

Group Type OTHER

Treatment with surgical standard of care

Intervention Type PROCEDURE

Interventions

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Treatment with investigational method (virtual implant positioning system)

Intervention Type PROCEDURE

Treatment with surgical standard of care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with diastal fracture of the radius
* Patients with the mentioned fracture and indication for surgical treatment according to national guidelines
* Age \>/= 18 years of age
* Patients willing to participate and after having given their informed consent in written form

Exclusion Criteria

* Participation in other interventional clinical trials
* Pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Healthcare QT

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kleinszig Gerhard, MSc

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Siemens AG Healthcare Sector

Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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10308644 Final 2.5

Identifier Type: -

Identifier Source: org_study_id

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