Standing Computed Tomography (SCT) Imaging of the Knee Joint

Sponsor
Neil A Segal (Other)
Overall Status
Completed
CT.gov ID
NCT03446404
Collaborator
University of Kansas (Other)
826
1
48.3
17.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Standing Computed Tomography

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.

Study Design

Study Type:
Observational
Actual Enrollment :
826 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Standing Computerized Tomography (SCT) Imaging of the Knee Joint in People With or at Risk for Knee Osteoarthritis (KOA)
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Mar 9, 2020
Actual Study Completion Date :
Mar 9, 2020

Arms and Interventions

Arm Intervention/Treatment
MOST Cohort

One portion of the cohort will be age 62-92 years, average age approximately 71 years, at the start of this study. This cohort will consist of participants who already have symptomatic knee OA, in many cases advanced disease, or who had risk factors at the start of the Multicenter Osteoarthritis Study but have not developed symptomatic knee OA. All of the existing cohort who have 1 or 2 "native" knees will be approached providing native knees are not considered to be Kellgren-Lawrence grade 4 (bone on bone). The other portion of the cohort will consist of subjects with knee pain, aching or stiffness at baseline and participants without any knee symptoms in the previous 30 days. Both knees with Kellgren-Lawrence grades of radiographic OA of 0, 1, or 2 in the tibiofemoral (TF) and patellofemoral (PF) compartments.

Diagnostic Test: Standing Computed Tomography
Provides weight bearing 3D view of knees.
Other Names:
  • SCT
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Joint Space Width [Baseline and 2-years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 92 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Neil A Segal
    • University of Kansas

    Investigators

    • Principal Investigator: Neil A Segal, MD, MS, University of Iowa and University of Kansas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Neil A Segal, Adjunct Professor, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT03446404
    Other Study ID Numbers:
    • 201602741
    First Posted:
    Feb 26, 2018
    Last Update Posted:
    May 26, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2021