Microcirculation of the Caput FemorisMicroFemNeckNCT01483404
Identification of the Microcirculation of the Caput Femoris After Fracture of the Femoral Neck
An observational study of Microcirculation of the Caput Femoris, run by RWTH Aachen University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microcirculation of the Caput Femoris
- What is being tested?
- Measurement with O2c
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jun 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 with fracture of the femural neck, who are treated in the University Hospital Aachen
Who may be able to join
- medial fracture of the femural neck
- surgical treatment (hip replacement)
Who cannot join
- pathologic fracture
- conservative treatment
- soft tissue damage
- delay of surgery more than 3 days
- Immune default
- polytrauma
Trial locations and contacts
1 site in 1 country.
Germany1 site
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Identification of Microcirculation in Fracture of the Femural Neck: How Does the Intracapsular Hematoma Affect the Capillary Bloodflow in the Caput Femoris?
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
- Being tested
- Measurement with O2c
- Keywords
- microcirculation, caput femoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement with O2cProcedure or surgery
Intra-surgery measurement of the microcirculation with the O2c device
| Study group | Role | What they receive |
|---|---|---|
| Patient with fracture of femural neck | All patient with fracture of the femural neck in the listed period of time 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 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
Four values are measured:
oxygen saturation local Hb local blood flow local blood velocity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startJun 2012
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcirculation of the Caput FemorisStudies 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
- 0 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, Chief of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483404
- Sponsor's protocol ID
- CTC-A10-30
- Acronym
- MicroFemNeck
- Status last verified
- Nov 2012
- First submitted
- 29 Nov 2011
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Microcirculation in Fracture of the Femural Neck: How Does the Intracapsular Hematoma Affect the Capillary Bloodflow in the Caput Femoris?
- ClinicalTrials.gov ID
- NCT01483404
- Acronym / sponsor ID
- MicroFemNeck / CTC-A10-30
- Conditions
- Microcirculation of the Caput Femoris
- Keywords
- microcirculation, caput femoris
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 1 Dec 2011 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with fracture of femural neck | – | Procedure: Measurement with O2cAll patient with fracture of the femural neck in the listed period of time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with fracture of the femural neck, who are treated in the University Hospital Aachen
Key inclusion criteria (2 listed)
- medial fracture of the femural neck
- surgical treatment (hip replacement)
Key exclusion criteria (6 listed)
- pathologic fracture
- conservative treatment
- soft tissue damage
- delay of surgery more than 3 days
- Immune default
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 O2cIntra-surgery measurement of the microcirculation with the O2c device | Procedure or surgery | Patient with fracture of femural neck |
Primary outcome
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
1 secondary outcome
Microcirculaiton of the caput femoris after the capusla of the joint has been surgically opened and the hematoma has been removed
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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
Chief of medicine
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 Microcirculation of the Caput Femoris, 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 2 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: withdrawn, as of the sponsor's last update on 12 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 was withdrawn before enrolling participants, so there are no results.
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 femoris befor the capsula of the joint is opend. 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 12 Nov 2012.