Osteoarthritis, KneeNCT03446404
Standing Computed Tomography (SCT) Imaging of the Knee Joint
An observational study of Osteoarthritis, Knee, run by Neil A Segal at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Standing Computed Tomography
- How many people
- 826 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 9 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 92 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Bilateral Total Knee Arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standing Computerized Tomography (SCT) Imaging of the Knee Joint in People With or at Risk for Knee Osteoarthritis (KOA)
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Standing Computed Tomography
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standing Computed TomographyDiagnostic test
Also called SCT
Provides weight bearing 3D view of knees.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Standing Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Joint Space Width
3D measurement of distance between articular surfaces of tibia and femur
Measured: Baseline and 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Mar 2016
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neil A Segal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas
- Responsible party
- Sponsor-investigator, Neil A Segal, University of Iowa
- Investigators
- Neil A Segal, MD, MS, Principal investigator, University of Iowa and University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446404
- Sponsor's protocol ID
- 201602741
- Status last verified
- May 2021
- First submitted
- 19 Feb 2018
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: As an ancillary study to the Multicenter Osteoarthritis Study (MOST), data will be available to other researchers through the MOST Data Sharing Plan.
Publications
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.
PubMed 26991547Segal 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.
PubMed 26313455Segal 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.
PubMed 25779857Sheehy 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.
PubMed 26003948Stefanik 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.
PubMed 25575967
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standing Computerized Tomography (SCT) Imaging of the Knee Joint in People With or at Risk for Knee Osteoarthritis (KOA)
- ClinicalTrials.gov ID
- NCT03446404
- Acronym / sponsor ID
- 201602741
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 826 participants (actual)
- Lead sponsor
- Neil A SegalUniversity, hospital or other
- Collaborators
- University of Kansas
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOST Cohort | – | Diagnostic Test: Standing Computed TomographyOne 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. |
Who may qualify
- Ages
- 45 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Bilateral Total Knee Arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standing Computed TomographyAlso: SCTProvides weight bearing 3D view of knees. | Diagnostic test | MOST Cohort |
Primary outcome
Change in Joint Space Width
Time frame: Baseline and 2-years
3D measurement of distance between articular surfaces of tibia and femur
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Background: PubMed 26991547Segal 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.
- Background: PubMed 26313455Segal 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.
- Background: PubMed 25779857Segal 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.
- Background: PubMed 26003948Sheehy 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.
- Background: PubMed 25575967Stefanik 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.
- Individual participant dataSharing planned: Yes. As an ancillary study to the Multicenter Osteoarthritis Study (MOST), data will be available to other researchers through the MOST Data Sharing Plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil A Segal, MD, MS principal investigator
University of Iowa and University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Neil A Segal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Joint Space Width (time frame: Baseline and 2-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446404, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.