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Standing Computed Tomography (SCT) Imaging of the Knee Joint

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ClinicalTrials.gov Identifier: NCT03446404
Recruitment Status : Active, not recruiting
First Posted : February 26, 2018
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
University of Kansas
Information provided by (Responsible Party):
Neil A Segal, University of Iowa

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
Osteoarthritis, Knee Diagnostic Test: Standing Computed Tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 826 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 : March 1, 2016
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


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 Name: SCT




Primary Outcome Measures :
  1. Change in Joint Space Width [ Time Frame: Baseline and 2-years ]
    3D measurement of distance between articular surfaces of tibia and femur



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Ages Eligible for Study:   45 Years to 92 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03446404


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Neil A Segal
University of Kansas
Investigators
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Principal Investigator: Neil A Segal, MD, MS University of Iowa and University of Kansas

Publications:

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Responsible Party: Neil A Segal, Adjunct Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03446404     History of Changes
Other Study ID Numbers: 201602741
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As an ancillary study to the Multicenter Osteoarthritis Study (MOST), data will be available to other researchers through the MOST Data Sharing Plan.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Following study completion (anticipated August 2021)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases