Proximal Femur FracturesNCT01660490
Development and Validation of Intraoperative Image-quality Criteria
An observational study of Proximal Femur Fractures, run by AO Clinical Investigation and Publishing Documentation at 3 sites in 3 countries.
Trial summary
An expert panel of surgeons agreed that there is not any established, standardized approach to the teaching of intraoperative imaging and that there may be practice gaps in decision making and the use of imaging among trauma surgeons. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proximal Femur Fractures
- What is being tested?
- ORIF
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2012to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a proximal femur fractures treated with ORIF between May 2010 and December 2010
Who may be able to join
- Diagnosis of proximal femur fracture
- Operated between May 2010 and December 2010
- Open Reduction Internal Fixation (ORIF)
- Lateral and anteroposterior intraoperative images available
Who cannot join
- None
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Development and Validation of Intraoperative Image-quality Criteria A Retrospective Multicenter Case Series to Validate a Set of Intraoperative Image-quality Criteria
An expert panel of surgeons agreed that there is not any established, standardized approach to the teaching of intraoperative imaging and that there may be practice gaps in decision making and the use of imaging among trauma surgeons.
The panel is set to initiate a consensus-based evaluation process to develop a list of criteria for assessing images and would like to validate these criteria for differentiating good quality versus poor quality images in term of reliability and accuracy.
- Conditions
- Proximal Femur Fractures
- Being tested
- ORIF
- Keywords
- Radiographic Image Enhancement,, Intraoperative Care, Femoral Fractures, Femoral Neck Fractures, Hip Fractures, Internal Fixators, Fracture Fixation Internal, Fracture Fixation Intramedullary, Fractures Bone
- Medical subject headings
- Proximal Femoral Fractures, Femoral Fractures, Femoral Neck Fractures, Hip Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIFProcedure or surgery
Open reduction internal fixation of the proximal femur
| Study group | Role | What they receive |
|---|---|---|
| Proximal femur fractures with ORIF | Proximal femur fractures treated with ORIF Receives: Procedure: ORIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate if C-Arm pictures can be a predictive factor for the outcome of repositioning of humerus fractures.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Femur 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Blauth, Professor, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660490
- Sponsor's protocol ID
- IO Image Quality
- Status last verified
- Mar 2014
- First submitted
- 6 Aug 2012
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Intraoperative Image-quality Criteria A Retrospective Multicenter Case Series to Validate a Set of Intraoperative Image-quality Criteria
- ClinicalTrials.gov ID
- NCT01660490
- Acronym / sponsor ID
- IO Image Quality
- Conditions
- Proximal Femur Fractures
- Keywords
- Radiographic Image Enhancement,, Intraoperative Care, Femoral Fractures, Femoral Neck Fractures, Hip Fractures, Internal Fixators, Fracture Fixation Internal, Fracture Fixation Intramedullary, Fractures Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Aug 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.
An expert panel of surgeons agreed that there is not any established, standardized approach to the teaching of intraoperative imaging and that there may be practice gaps in decision making and the use of imaging among trauma surgeons.
The panel is set to initiate a consensus-based evaluation process to develop a list of criteria for assessing images and would like to validate these criteria for differentiating good quality versus poor quality images in term of reliability and accuracy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proximal femur fractures with ORIF | – | Procedure: ORIFProximal femur fractures treated with ORIF |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a proximal femur fractures treated with ORIF between May 2010 and December 2010
Key inclusion criteria (4 listed)
- Diagnosis of proximal femur fracture
- Operated between May 2010 and December 2010
- Open Reduction Internal Fixation (ORIF)
- Lateral and anteroposterior intraoperative images available
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ORIFOpen reduction internal fixation of the proximal femur | Procedure or surgery | Proximal femur fractures with ORIF |
Primary outcome
Evaluate if C-Arm pictures can be a predictive factor for the outcome of repositioning of humerus fractures.
Time frame: Intraoperatively
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 19 Mar 2014.
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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.
Michael Blauth, Professor principal investigator
Medical University Innsbruck
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Femur Fractures, run by AO Clinical Investigation and Publishing Documentation at 3 sites in 3 countries.
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 4 inclusion and 1 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Austria, Switzerland. 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?
Evaluate if C-Arm pictures can be a predictive factor for the outcome of repositioning of humerus fractures. (time frame: Intraoperatively). 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 19 Mar 2014.