Identification of the Microcirculation of the Caput Femoris After Fracture of the Femoral Neck (MicroFemNeck)

November 9, 2012 updated by: RWTH Aachen University

Identification of Microcirculation in Fracture of the Femural Neck: How Does the Intracapsular Hematoma Affect the Capillary Bloodflow in the Caput Femoris?

This project investigates wether the intra-capsular hematoma, that often occurs after fracture of the femural neck, decreases the capillary blood flow of the caput femoris.

During operation the measuring device of the O2c-machine in placed on the joint capsula first and afterwards, after surgical opening of the capsula, on the femur directly. The integral of the microcirculation of both parts of the femur is measured in both settings. So the capillary blood flow is measured with the hematoma still in situ, eventually putting pressure on the caput femoris and after the capsula has been opened, the pressure relieved and the hematoma removed. Both measurements are compared for each patient.

The O2c-machine measures non-invasive with light waves and laser-doppler. The sounding rod is packed in a sterile tube to prevent any contamination of the operation site.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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
    • NRW
      • Aachen, NRW, 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 with fracture of the femural neck, who are treated in the University Hospital Aachen

Description

Inclusion Criteria:

  • medial fracture of the femural neck
  • surgical treatment (hip replacement)

Exclusion Criteria:Polytrauma

  • pathologic fracture
  • conservative treatment
  • soft tissue damage
  • delay of surgery more than 3 days
  • Immune default
  • polytrauma

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with fracture of femural neck
All patient with fracture of the femural neck in the listed period of time
Procedure: Measurement with O2c
Intra-surgery measurement of the microcirculation with the O2c device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Microcirculation of the caput femoris befor the capsula of the joint is opend

Four Values are measured:

oxygen saturation local Hb local blood flow local blood velocity

Secondary Outcome Measures

Outcome Measure
Measure Description
Microcirculaiton of the caput femoris after the capusla of the joint has been surgically opened and the hematoma has been removed

Four values are measured:

oxygen saturation local Hb local blood flow local blood velocity

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, Chief of medicine

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

June 1, 2012

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Estimate)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 9, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTC-A10-30

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.

Clinical Trials on Microcirculation of the Caput Femoris

Clinical Trials on Measurement with O2c

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe