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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This study has been withdrawn prior to enrollment.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
History of Changes

November 29, 2011
November 9, 2012
June 2012
November 2012   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01483404 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Identification of the Microcirculation of the Caput Femoris After Fracture of the Femoral Neck
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

All patients with fracture of the femural neck, who are treated in the University Hospital Aachen
Microcirculation of the Caput Femoris
Procedure: Measurement with O2c
Intra-surgery measurement of the microcirculation with the O2c device
Patient with fracture of femural neck
All patient with fracture of the femural neck in the listed period of time
Intervention: Procedure: Measurement with O2c
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01483404
CTC-A10-30
Yes
RWTH Aachen University
RWTH Aachen University
Not Provided
Study Chair: Hans-Christoph Pape, Univ-prof.MD Chief of medicine
RWTH Aachen University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP