NCT01737385

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

November 27, 2012

Last Update Submit

November 28, 2012

Conditions

Proximal Humeral Fractures

Keywords

microcirculationproximal humeral fracturesO2C

Outcome Measures

Primary Outcomes (1)

  • microcirculation of the caput humeri

    oxygen saturation, haemoglobin, blood flow, velocity of blood flow

    during surgery

Study Arms (4)

Type 1

One segment fracture

Procedure: Measurement with O2C

Type 2

Two segment fracture

Procedure: Measurement with O2C

Type 3

Three segment fracture

Procedure: Measurement with O2C

Type 4

Four segment fracture

Procedure: Measurement with O2C

Interventions

Measurement with O2CPROCEDURE

Measurement of microcirculation using O2C light probes.

Type 1Type 2Type 3Type 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • traumatic fractures of the proximal humerus
  • surgical treatment
  • over eighteen years of age

You may not qualify if:

  • pathological fractures
  • conservative treatment
  • soft tissue damage
  • delay of surgery more than three days
  • immunological defects
  • multiple trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RWTH Aachen University Hospital

Aachen, Nordrheinwestfalen, 52074, Germany

Location

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Hans-Christoph Pape, Univ.-Prof MD

    Dpt. of Orthopedic Trauma, RWTH Aachen University

    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 27, 2012

First Posted

November 29, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

DE(1)