Standing Computed Tomography (SCT) Imaging of the Knee Joint

NCT03446404 | Completed FDA Device

• 1 other identifier: 201602741
• Study Type: observational
• Target: 826
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Change in Joint Space Width

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

  Baseline and 2-years

Study Arms (1)

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

Interventions

Standing Computed Tomography DIAGNOSTIC_TEST

Provides weight bearing 3D view of knees.

Also known as: SCT

MOST Cohort

Eligibility Criteria

• Age: 45 Years - 92 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The existing 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 MOST 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 KL grade 4 (bone on bone). The new 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 KL grades of radiographic OA of 0, 1, or 2 in the tibiofemoral (TF) and patellofemoral (PF) compartments.

You may qualify if:

• Completed knee radiograph (posteroanterior view) at 0/144-month visit of primary MOST-second renewal study at the Iowa Site

You may not qualify if:

• Bilateral Total Knee Arthroplasty

Sponsors & Collaborators

• Neil A Segal: lead
• University of Kansas: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

• 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.

  PMID: 26991547 BACKGROUND

• 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.

  PMID: 26313455 BACKGROUND

• 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.

  PMID: 25779857 BACKGROUND

• 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.

  PMID: 26003948 BACKGROUND

• 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.

  PMID: 25575967 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Neil A Segal, MD, MS

  University of Iowa and University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 26, 2018
• Study Start: March 1, 2016
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following study completion (anticipated August 2021)

Locations

US (1)