Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture

NCT ID: NCT01737385

Last Updated: 2012-11-29

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

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-11-30

Brief Summary

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This study examines the microcirculation of the caput humeri after proximal humeral fracturation using O2C light probes.

During the operation the blood circulation is measured at four points (tuberculum majus, tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. The data is analysed in respect to the fracture type according to the classification of Neer.

Valuable additional information for the correct treatment and prognosis of humeral fractures is expected.

Detailed Description

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Conditions

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Proximal Humeral Fractures

Keywords

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microcirculation proximal humeral fractures O2C

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1

One segment fracture

Measurement with O2C

Intervention Type PROCEDURE

Measurement of microcirculation using O2C light probes.

Type 2

Two segment fracture

Measurement with O2C

Intervention Type PROCEDURE

Measurement of microcirculation using O2C light probes.

Type 3

Three segment fracture

Measurement with O2C

Intervention Type PROCEDURE

Measurement of microcirculation using O2C light probes.

Type 4

Four segment fracture

Measurement with O2C

Intervention Type PROCEDURE

Measurement of microcirculation using O2C light probes.

Interventions

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Measurement with O2C

Measurement of microcirculation using O2C light probes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* traumatic fractures of the proximal humerus
* surgical treatment
* over eighteen years of age

Exclusion Criteria

* pathological fractures
* conservative treatment
* soft tissue damage
* delay of surgery more than three days
* immunological defects
* multiple trauma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans-Christoph Pape, Univ.-Prof MD

Role: STUDY_CHAIR

Dpt. of Orthopedic Trauma, RWTH Aachen University

Locations

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RWTH Aachen University Hospital

Aachen, Nordrheinwestfalen, Germany

Site Status

Countries

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Germany

Other Identifiers

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CTC-A10-31

Identifier Type: -

Identifier Source: org_study_id