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

Withdrawn

• Conditions: Microcirculation of the Caput Femoris
• Interventions: Procedure: Measurement with O2c

• Registration Number: NCT01483404
• Lead Sponsor: RWTH Aachen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-12-01
• Study Start: 2012-06
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-09
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with fracture of femural neck	Measurement with O2c	All patient with fracture of the femural neck in the listed period of time

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

RWTH Aachen University Hospital; 🇩🇪 Aachen, NRW, Germany