Standing Computed Tomography (SCT) Imaging of the Knee Joint

NCT ID: NCT03446404

Last Updated: 2021-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

826 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2020-03-09

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Standing Computed Tomography

Intervention Type DIAGNOSTIC_TEST

Provides weight bearing 3D view of knees.

Interventions

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Standing Computed Tomography

Provides weight bearing 3D view of knees.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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SCT

Eligibility Criteria

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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.


* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

92 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kansas

OTHER

Sponsor Role collaborator

Neil A Segal

OTHER

Sponsor Role lead

Responsible Party

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Neil A Segal

Adjunct Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Neil A Segal, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa and University of Kansas

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Segal NA, Frick E, Duryea J, Roemer F, Guermazi A, Nevitt MC, Torner JC, Felson DT, Anderson DD. Correlations of Medial Joint Space Width on Fixed-Flexed Standing Computed Tomography and Radiographs With Cartilage and Meniscal Morphology on Magnetic Resonance Imaging. Arthritis Care Res (Hoboken). 2016 Oct;68(10):1410-6. doi: 10.1002/acr.22888.

Reference Type BACKGROUND
PMID: 26991547 (View on PubMed)

Segal NA, Nevitt MC, Lynch JA, Niu J, Torner JC, Guermazi A. Diagnostic performance of 3D standing CT imaging for detection of knee osteoarthritis features. Phys Sportsmed. 2015 Jul;43(3):213-20. doi: 10.1080/00913847.2015.1074854. Epub 2015 Aug 3.

Reference Type BACKGROUND
PMID: 26313455 (View on PubMed)

Segal NA, Stockman TJ, Findlay CM, Kern AM, Ohashi K, Anderson DD. Effect of a Realigning Brace on Tibiofemoral Contact Stress. Arthritis Care Res (Hoboken). 2015 Aug;67(8):1112-8. doi: 10.1002/acr.22578.

Reference Type BACKGROUND
PMID: 25779857 (View on PubMed)

Sheehy L, Culham E, McLean L, Niu J, Lynch J, Segal NA, Singh JA, Nevitt M, Cooke TD. Validity and sensitivity to change of three scales for the radiographic assessment of knee osteoarthritis using images from the Multicenter Osteoarthritis Study (MOST). Osteoarthritis Cartilage. 2015 Sep;23(9):1491-8. doi: 10.1016/j.joca.2015.05.003. Epub 2015 May 21.

Reference Type BACKGROUND
PMID: 26003948 (View on PubMed)

Stefanik JJ, Gross KD, Guermazi A, Felson DT, Roemer FW, Zhang Y, Niu J, Segal NA, Lewis CE, Nevitt M, Neogi T. The relation of MRI-detected structural damage in the medial and lateral patellofemoral joint to knee pain: the Multicenter and Framingham Osteoarthritis Studies. Osteoarthritis Cartilage. 2015 Apr;23(4):565-70. doi: 10.1016/j.joca.2014.12.023. Epub 2015 Jan 7.

Reference Type BACKGROUND
PMID: 25575967 (View on PubMed)

Other Identifiers

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201602741

Identifier Type: -

Identifier Source: org_study_id

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