Proximal Humeral FracturesNCT01737385
Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture
An observational study of Proximal Humeral Fractures, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fractures
- What is being tested?
- Measurement with O2C
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that are treated for proximal humeral fratures in the University hospital of the RWTH Aachen University.
Who may be able to join
- traumatic fractures of the proximal humerus
- surgical treatment
- over eighteen years of age
Who cannot join
- pathological fractures
- conservative treatment
- soft tissue damage
- delay of surgery more than three days
- immunological defects
- multiple trauma
Trial locations and contacts
1 site in 1 country.
Germany1 site
RWTH Aachen University Hospital
Aachen, Nordrheinwestfalen, 52074
About this study
Official title: Intraoperative Examination of Microcirculation of the Caput Humeri After Traumatic Proximal Humerus Fracturation.
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.
- Conditions
- Proximal Humeral Fractures
- Being tested
- Measurement with O2C
- Keywords
- microcirculation, proximal humeral fractures, O2C
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement with O2CProcedure or surgery
Measurement of microcirculation using O2C light probes.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 | One segment fracture Receives: Procedure: Measurement with O2C | |
| Type 2 | Two segment fracture Receives: Procedure: Measurement with O2C | |
| Type 3 | Three segment fracture Receives: Procedure: Measurement with O2C | |
| Type 4 | Four segment fracture Receives: Procedure: Measurement with O2C |
What is being measured
The primary outcome is the main question the study is designed to answer.
microcirculation of the caput humeri
oxygen saturation, haemoglobin, blood flow, velocity of blood flow
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans-Christoph Pape, Univ.-Prof MD, Study chair, Dpt. of Orthopedic Trauma, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737385
- Sponsor's protocol ID
- CTC-A10-31
- Status last verified
- Nov 2012
- First submitted
- 27 Nov 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Examination of Microcirculation of the Caput Humeri After Traumatic Proximal Humerus Fracturation.
- ClinicalTrials.gov ID
- NCT01737385
- Acronym / sponsor ID
- CTC-A10-31
- Conditions
- Proximal Humeral Fractures
- Keywords
- microcirculation, proximal humeral fractures, O2C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type 1 | – | Procedure: Measurement with O2COne segment fracture |
| Type 2 | – | Procedure: Measurement with O2CTwo segment fracture |
| Type 3 | – | Procedure: Measurement with O2CThree segment fracture |
| Type 4 | – | Procedure: Measurement with O2CFour segment fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that are treated for proximal humeral fratures in the University hospital of the RWTH Aachen University.
Key inclusion criteria (3 listed)
- traumatic fractures of the proximal humerus
- surgical treatment
- over eighteen years of age
Key exclusion criteria (6 listed)
- pathological fractures
- conservative treatment
- soft tissue damage
- delay of surgery more than three days
- immunological defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement with O2CMeasurement of microcirculation using O2C light probes. | Procedure or surgery | Type 1, Type 2, Type 3, Type 4 |
Primary outcome
microcirculation of the caput humeri
Time frame: during surgery
oxygen saturation, haemoglobin, blood flow, velocity of blood flow
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Christoph Pape, Univ.-Prof MD study chair
Dpt. of Orthopedic Trauma, RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fractures, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microcirculation of the caput humeri (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.