Patellar (or Kneecap) Instability and Mal-alignmentPFNCT02257099
CT Analysis of the Patellofemoral Joint in Patients Having Knee Surgery
An observational study of Patellar (or Kneecap) Instability and Mal-alignment, run by State University of New York at Buffalo at 2 sites in United States.
Trial summary
The primary hypothesis is that measures of patellofemoral alignment obtained from the investigational cone beam CT scanner will be reduced, but still correlated to those obtained from the conventional CT scan. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Patellar (or Kneecap) Instability and Mal-alignment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have been diagnosed with acute or chronic patellar malalignment.
Who may be able to join
- Patients who have been diagnosed with acute or chronic patellar malalignment.
- At least 16 years old
- Be willing and able to provide informed consent
Who cannot join
- Open growth plates
- Previous knee surgery on the affected knee
- Pregnancy (females)
- Fracture of the patellofemoral joint
- Knee ligament injury (other than medial patellofemoral ligament)
- Have greater than Grade II degenerative changes of the patellofemoral joint
- Inability to bear weight on the extremity during the CT scan
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UBMD Orthopaedics and Sports Medicine, Northtowns office
Amherst, New York, 14226
UBMD Orthopaedics and Sports Medicine, Southtowns Office
Orchard Park, New York, 14127
About this study
Official title: Comparison of a Novel Weight Bearing Cone Beam Computed Tomography (CT)Scanner Versus a Conventional CT Scanner for Measuring Patellar Instability
The primary hypothesis is that measures of patellofemoral alignment obtained from the investigational cone beam CT scanner will be reduced, but still correlated to those obtained from the conventional CT scan.
- Medical subject headings
- Patella Fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
Congruence Angle CBCT
Measured: Baseline
Secondary outcomes (2)
Tilt Angle
Measured: Baseline
Tibial Tuberosity Trochlear Groove
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patellar (or Kneecap) Instability and Mal-alignmentStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Carestream Health, Inc.
- Responsible party
- Principal investigator, John Marzo, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257099
- Sponsor's protocol ID
- 655951-1
- Acronym
- PF
- Status last verified
- Sep 2019
- First submitted
- 29 Sep 2014
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Weight Bearing Cone Beam Computed Tomography (CT)Scanner Versus a Conventional CT Scanner for Measuring Patellar Instability
- ClinicalTrials.gov ID
- NCT02257099
- Acronym / sponsor ID
- PF / 655951-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Carestream Health, Inc.
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis is that measures of patellofemoral alignment obtained from the investigational cone beam CT scanner will be reduced, but still correlated to those obtained from the conventional CT scan.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have been diagnosed with acute or chronic patellar malalignment.
Key inclusion criteria (3 listed)
- Patients who have been diagnosed with acute or chronic patellar malalignment.
- At least 16 years old
- Be willing and able to provide informed consent
Key exclusion criteria (7 listed)
- Open growth plates
- Previous knee surgery on the affected knee
- Pregnancy (females)
- Fracture of the patellofemoral joint
- Knee ligament injury (other than medial patellofemoral ligament)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Congruence Angle CBCT
Time frame: Baseline
2 secondary outcomes
Tilt Angle
Time frame: Baseline
Tibial Tuberosity Trochlear Groove
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellar (or Kneecap) Instability and Mal-alignment, run by State University of New York at Buffalo at 2 sites in United States.
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 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Congruence Angle CBCT (time frame: Baseline). 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 3 Oct 2019.