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CT Analysis of the Patellofemoral Joint in Patients Having Knee Surgery (PF)

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ClinicalTrials.gov Identifier: NCT02257099
Recruitment Status : Completed
First Posted : October 6, 2014
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Carestream Health, Inc.
Information provided by (Responsible Party):
John Marzo, State University of New York at Buffalo

Brief 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.

Condition or disease
Patellar (or Kneecap) Instability and Mal-alignment

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Comparison of a Novel Weight Bearing Cone Beam Computed Tomography (CT)Scanner Versus a Conventional CT Scanner for Measuring Patellar Instability
Study Start Date : February 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016



Primary Outcome Measures :
  1. Congruence Angle CBCT [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Tilt Angle [ Time Frame: Baseline ]
  2. Tibial Tuberosity Trochlear Groove [ Time Frame: Baseline ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been diagnosed with acute or chronic patellar malalignment.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257099


Locations
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United States, New York
UBMD Orthopaedics and Sports Medicine, Northtowns office
Amherst, New York, United States, 14226
UBMD Orthopaedics and Sports Medicine, Southtowns Office
Orchard Park, New York, United States, 14127
Sponsors and Collaborators
State University of New York at Buffalo
Carestream Health, Inc.
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Responsible Party: John Marzo, Associate Professor of Clinical Orthopaedics, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02257099    
Other Study ID Numbers: 655951-1
First Posted: October 6, 2014    Key Record Dates
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019
Last Verified: September 2019