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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01483404
First received: November 29, 2011
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Microcirculation of the Caput Femoris
Procedure: Measurement with O2c

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Microcirculation in Fracture of the Femural Neck: How Does the Intracapsular Hematoma Affect the Capillary Bloodflow in the Caput Femoris?

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Microcirculation of the caput femoris befor the capsula of the joint is opend [ Designated as safety issue: No ]

    Four Values are measured:

    oxygen saturation local Hb local blood flow local blood velocity



Secondary Outcome Measures:
  • Microcirculaiton of the caput femoris after the capusla of the joint has been surgically opened and the hematoma has been removed [ Designated as safety issue: No ]

    Four values are measured:

    oxygen saturation local Hb local blood flow local blood velocity



Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with fracture of the femural neck, who are treated in the University Hospital Aachen

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483404

Locations
Germany
RWTH Aachen University Hospital
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Chair: Hans-Christoph Pape, Univ-prof.MD Chief of medicine
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01483404     History of Changes
Other Study ID Numbers: CTC-A10-30
Study First Received: November 29, 2011
Last Updated: November 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
microcirculation
caput femoris

ClinicalTrials.gov processed this record on September 18, 2014