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Clinical Trials/NCT03446404
NCT03446404
Completed
Not Applicable

Standing Computerized Tomography (SCT) Imaging of the Knee Joint in People With or at Risk for Knee Osteoarthritis (KOA)

Neil A Segal1 site in 1 country826 target enrollmentMarch 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Neil A Segal
Enrollment
826
Locations
1
Primary Endpoint
Change in Joint Space Width
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study will help us decide the best way to image the knee for diagnostic purposes: Knee computed tomography vs knee x-ray. The computed tomography will provide a weight bearing 3D view.

Detailed Description

This will be an ancillary study to the Multicenter Osteoarthritis Study (MOST) second renewal #201511711). Using a prototype Curve Beam Standing Computed Tomography (SCT) scanner to get a 3 dimensional picture of the knee joint, bilaterally. This scanner by Curve Beam 175 Titus Ave, Suite 300, Warrington, Pennsylvania 18976, has been approved by the Food and Drug Administration (FDA) for ankles and feet. This has been modified to do the scan of the knee but is not yet approved by the FDA for the knees. The proposed ancillary study would add the key benefit of providing more sensitive and accurate identification of prevalent knee osteoarthritis (OA) at baseline and incident knee OA at follow-up than is available with plain radiographs. In addition, it would enable biomechanical modeling of the knee joint on a larger scale than achieved in any prior study, allowing testing of biomechanical hypotheses regarding mechanisms of disease development and progression that have not been possible on this scale previously.

Registry
clinicaltrials.gov
Start Date
March 1, 2016
End Date
March 9, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Neil A Segal
Responsible Party
Sponsor Investigator
Principal Investigator

Neil A Segal

Adjunct Professor

University of Iowa

Eligibility Criteria

Inclusion Criteria

  • Only participants in the Multicenter Osteoarthritis Study (MOST) who attend a 0/144-month visit at the Iowa site are eligible for inclusion.
  • Additional Inclusion Criteria Include:
  • Completed knee radiograph (posteroanterior view) at 0/144-month visit of primary MOST-second renewal study at the Iowa Site

Exclusion Criteria

  • Bilateral Total Knee Arthroplasty

Outcomes

Primary Outcomes

Change in Joint Space Width

Time Frame: Baseline and 2-years

3D measurement of distance between articular surfaces of tibia and femur

Study Sites (1)

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