Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture

November 28, 2012 updated by: RWTH Aachen University

Intraoperative Examination of Microcirculation of the Caput Humeri After Traumatic Proximal Humerus Fracturation.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrheinwestfalen
      • Aachen, Nordrheinwestfalen, Germany, 52074
        • RWTH Aachen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients that are treated for proximal humeral fratures in the University hospital of the RWTH Aachen University.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1
One segment fracture
Procedure: Measurement with O2C
Measurement of microcirculation using O2C light probes.
Type 2
Two segment fracture
Procedure: Measurement with O2C
Measurement of microcirculation using O2C light probes.
Type 3
Three segment fracture
Procedure: Measurement with O2C
Measurement of microcirculation using O2C light probes.
Type 4
Four segment fracture
Procedure: Measurement with O2C
Measurement of microcirculation using O2C light probes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microcirculation of the caput humeri
Time Frame: during surgery
oxygen saturation, haemoglobin, blood flow, velocity of blood flow
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Study Chair: Hans-Christoph Pape, Univ.-Prof MD, Dpt. of Orthopedic Trauma, RWTH Aachen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (ESTIMATE)

November 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 29, 2012

Last Update Submitted That Met QC Criteria

November 28, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC-A10-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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