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Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01737385
First received: November 27, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Proximal Humeral Fractures
 Procedure: Measurement with O2C

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intraoperative Examination of Microcirculation of the Caput Humeri After Traumatic Proximal Humerus Fracturation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • microcirculation of the caput humeri [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    oxygen saturation, haemoglobin, blood flow, velocity of blood flow


Enrollment: 25
Study Start Date: May 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 1
One segment fracture
 Procedure: Measurement with O2C
Measurement of microcirculation using O2C light probes.
Type 2
Two segment fracture
 Procedure: Measurement with O2C
Measurement of microcirculation using O2C light probes.
Type 3
Three segment fracture
 Procedure: Measurement with O2C
Measurement of microcirculation using O2C light probes.
Type 4
Four segment fracture
 Procedure: Measurement with O2C
Measurement of microcirculation using O2C light probes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients that are treated for proximal humeral fratures in the University hospital of the RWTH Aachen University.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737385

Locations
Germany
RWTH Aachen University Hospital
Aachen, Nordrheinwestfalen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Chair: Hans-Christoph Pape, Univ.-Prof MD Dpt. of Orthopedic Trauma, RWTH Aachen University
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01737385     History of Changes
Other Study ID Numbers: CTC-A10-31
Study First Received: November 27, 2012
Last Updated: November 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
microcirculation
proximal humeral fractures
O2C

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on May 19, 2013