- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02257099
CT Analysis of the Patellofemoral Joint in Patients Having Knee Surgery (PF)
September 12, 2019 updated by: John Marzo, State University of New York at Buffalo
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Amherst, New York, United States, 14226
- UBMD Orthopaedics and Sports Medicine, Northtowns office
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Orchard Park, New York, United States, 14127
- UBMD Orthopaedics and Sports Medicine, Southtowns Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have been diagnosed with acute or chronic patellar malalignment.
Description
Inclusion Criteria:
- Patients who have been diagnosed with acute or chronic patellar malalignment.
- At least 16 years old
- Be willing and able to provide informed consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Congruence Angle CBCT
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tilt Angle
Time Frame: Baseline
|
Baseline
|
Tibial Tuberosity Trochlear Groove
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
September 29, 2014
First Submitted That Met QC Criteria
October 3, 2014
First Posted (Estimate)
October 6, 2014
Study Record Updates
Last Update Posted (Actual)
October 3, 2019
Last Update Submitted That Met QC Criteria
September 12, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 655951-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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