Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture

Proximal Humeral Fractures Clinical Trial

Official title:

Intraoperative Examination of Microcirculation of the Caput Humeri After Traumatic Proximal Humerus Fracturation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737385
• Other study ID #: CTC-A10-31
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: November 28, 2012
• Start date: May 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 study examines the microcirculation of the caput humeri after proximal humeral fracturation using O2C light probes.

During the operation the blood circulation is measured at four points (tuberculum majus, tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. The data is analysed in respect to the fracture type according to the classification of Neer.

Valuable additional information for the correct treatment and prognosis of humeral fractures is expected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• 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:

• traumatic fractures of the proximal humerus

• surgical treatment

• over eighteen years of age

Exclusion Criteria:

• pathological fractures

• conservative treatment

• soft tissue damage

• delay of surgery more than three days

• immunological defects

• multiple trauma

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fractures
• Shoulder Fractures

Intervention

Procedure:
• Measurement with O2C
Measurement of microcirculation using O2C light probes.

Locations

Country	Name	City	State
Germany	RWTH Aachen University Hospital	Aachen	Nordrheinwestfalen

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 humeri	oxygen saturation, haemoglobin, blood flow, velocity of blood flow	during surgery	No