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

Microcirculation of the Caput Femoris Clinical Trial

— MicroFemNeck  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01483404
• Other study ID #: CTC-A10-30
• Status: Withdrawn
• Phase: N/A
• First received: November 29, 2011
• Last updated: November 9, 2012
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Microcirculation of the Caput Femoris

Intervention

Procedure:
• Measurement with O2c
Intra-surgery measurement of the microcirculation with the O2c device

Locations

Country	Name	City	State
Germany	RWTH Aachen University Hospital	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No
Secondary	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		No