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

NCT01483404 | Withdrawn DMC

• 1 other identifier: CTC-A10-30
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Microcirculation of the Caput Femoris

Keywords

microcirculation; caput femoris

Outcome Measures

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

Study Arms (1)

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

Measurement with O2c PROCEDURE

Intra-surgery measurement of the microcirculation with the O2c device

Patient with fracture of femural neck

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• medial fracture of the femural neck
• surgical treatment (hip replacement)

You may not qualify if:

• pathologic fracture
• conservative treatment
• soft tissue damage
• delay of surgery more than 3 days
• Immune default
• polytrauma

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Hans-Christoph Pape, Univ-prof.MD

  Chief of medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 1, 2011
• Study Start: June 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

DE (1)