Standing Computed Tomography (SCT) Imaging of the Knee Joint

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446404
• Other study ID #: 201602741
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: March 9, 2020

Study information

• Verified date: May 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 826
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 92 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Diagnostic Test:
• Standing Computed Tomography
Provides weight bearing 3D view of knees.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Neil A Segal	University of Kansas

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Joint Space Width	3D measurement of distance between articular surfaces of tibia and femur	Baseline and 2-years