Patellofemoral JointNPFNCT02762630
Use of a Novel Weight Bearing Cone Beam Computed Tomography (CBCT) Scanner for Imaging of the Patellofemoral Joint
An observational study of Patellofemoral Joint, run by State University of New York at Buffalo.
Trial summary
Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess normal alignment of the knee joint Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Joint
- What is being tested?
- Carestream Health Inc. weight bearing cone beam CT scanner
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Sep 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Willing and able to provide written informed consent
- Be 16 or more years of age
- Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion during the images
Who cannot join
- Have a history of patella instability
- Have had any type of previous knee surgery
- Have had a significant fracture of the patellofemoral joint
- Have a knee ligament injury
- Are pregnant at the time of screening or become pregnant during the study
- Have a history of high radiation exposure (i.e., undergone radiation therapy)
- Non-English speakers
About this study
Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess normal alignment of the knee joint
- Conditions
- Patellofemoral Joint
- Being tested
- Carestream Health Inc. weight bearing cone beam CT scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carestream Health Inc. weight bearing cone beam CT scannerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibial tubercle-trochlear groove (TT-TG) offset distance (mm)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral JointStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Marzo, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762630
- Sponsor's protocol ID
- STUDY00000568
- Acronym
- NPF
- Status last verified
- Apr 2017
- First submitted
- 3 May 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel Weight Bearing Cone Beam Computed Tomography (CBCT) Scanner for Imaging of the Patellofemoral Joint
- ClinicalTrials.gov ID
- NCT02762630
- Acronym / sponsor ID
- NPF / STUDY00000568
- Conditions
- Patellofemoral Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 May 2016 (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.
Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess normal alignment of the knee joint
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Willing and able to provide written informed consent
- Be 16 or more years of age
- Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion during the images
Key exclusion criteria (7 listed)
- Have a history of patella instability
- Have had any type of previous knee surgery
- Have had a significant fracture of the patellofemoral joint
- Have a knee ligament injury
- Are pregnant at the time of screening or become pregnant during the study
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 |
|---|---|---|
| Carestream Health Inc. weight bearing cone beam CT scanner | Device | – |
Primary outcome
Tibial tubercle-trochlear groove (TT-TG) offset distance (mm)
Time frame: 1 day
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 27 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Joint, run by State University of New York at Buffalo.
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 7 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 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Tibial tubercle-trochlear groove (TT-TG) offset distance (mm) (time frame: 1 day). 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 27 Apr 2017.