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WithdrawnNCT01483404MicroFemNeckUpdated Nov 12, 2012

Identification of the Microcirculation of the Caput Femoris After Fracture of the Femoral Neck

An observational study in Microcirculation of the Caput Femoris, sponsored by RWTH Aachen University. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-12.

Sponsored by RWTH Aachen University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Microcirculation of the Caput Femoris

Keywords

  • microcirculation
  • caput femoris
03

In context

Lead sponsor

RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Eligibility 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • Patient with fracture of femural neck

    All patient with fracture of the femural neck in the listed period of time

    Procedure: Measurement with O2c

Interventions

  • ProcedureMeasurement with O2c

    Intra-surgery measurement of the microcirculation with the O2c device

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

1 site
  • RWTH Aachen University Hospital
    Aachen, NRW 52074, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01483404
Lead sponsor
RWTH Aachen University
Responsible party
Sponsor
First posted
Dec 1, 2011
Start date
Jun 2012
Primary completion
Nov 2012 (estimated)
Completion
Nov 2012 (estimated)
Last update
Nov 12, 2012

Study contacts

Hans-Christoph Pape, Univ-prof.MD
study chair · Chief of medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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