OsteoarthritisNCT02888119
Imaging Biomarkers of Knee Osteoarthritis
A study testing PRISMA 3T MRI scanner (Siemens Medical Solutions) in people with Osteoarthritis, run by NYU Langone Health at 1 site in United States.
Trial summary
This study aims to develop, evaluate and translate highly accelerated imaging sequences (each protocol under 5 minutes) for in-vivo knee Osteoarthritis applications on a standard clinical 3T scanner using novel compression sensing and parallel imaging strategies.The overarching objective of the study is to establish a… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- PRISMA 3T MRI scanner (Siemens Medical Solutions)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 13 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients in the HJD OA database, ages 40-75 with high risk of developing OA as defined by:
- KL score of 0 (ii) Knee pain present in at least 1 knee (iii) Normal radiographs, (iv) At least one abnormal clinical MR finding such as prior knee injury, overweight or traumatic bone marrow edema lesions
- Patients ages 40-75 with early OA as determined by KL scores 1-2
- Healthy controls in the HJD OA database (KL score 0, no knee pain, no meniscal or ligament tears)
Who cannot join
- Contraindications for MRIs (e.g. pacemakers, ferromagnetic vascular clips, metal implants, claustrophobia, etc).
- Subjects with any joint disease (example: Rheumatoid or inflammatory arthritis) other than knee OA, corticosteroid injections within the previous 3 months, and history of avascular necrosis, Paget's disease of bone, Wilson's disease, gout, total knee replacement (or plan for replacement within next 24 months).
- Major co-morbidities such as diabetes, mellitus, cancer, congestive heart failure and chronic infectious diseases.
- Alignment interventions such as insoles and knee braces
- Vulnerable patients will not be recruited for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This study aims to develop, evaluate and translate highly accelerated imaging sequences (each protocol under 5 minutes) for in-vivo knee Osteoarthritis applications on a standard clinical 3T scanner using novel compression sensing and parallel imaging strategies.The overarching objective of the study is to establish a non-invasive imaging biomarker based on the development of rapid relaxation mapping with compressed sensing (CS) that will be clinically useful for assessment of early Osteoarthritis. A total of 90 subjects including 30 patients with high risk of developing knee osteoarthritis (OA), 30 patients with mild OA and 30 healthy controls will be accrued.
Read the detailed description
Current noninvasive imaging methods to evaluate knee joints include plain radiographs, computed tomography (CT), and clinical morphological magnetic resonance imaging (MRI) of joint structures. These techniques can only detect later-stage, macroscopic joint structural abnormalities that are irreversible and not amenable to early therapy. This study aims to develop highly accelerated imaging sequences for ex-vivo knee OA applications on a standard clinical 3T scanner using novel CS and parallel imaging (PI) strategies.
- Conditions
- Osteoarthritis
- Being tested
- PRISMA 3T MRI scanner (Siemens Medical Solutions)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISMA 3T MRI scanner (Siemens Medical Solutions)Device
A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
| Study group | Role | What they receive |
|---|---|---|
| High Risk for Osteoarthritis | Active comparator | "High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions. Receives: Device: PRISMA 3T MRI scanner (Siemens Medical Solutions) |
| Mild Osteoarthritis | Active comparator | Not described Receives: Device: PRISMA 3T MRI scanner (Siemens Medical Solutions) |
| Healthy Controls | Active comparator | Controls will be age/gender matched to patients within 2 years of age. Receives: Device: PRISMA 3T MRI scanner (Siemens Medical Solutions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in T1ρ Relaxation Time
MRI exam of accelerated 3D-T1p conducted on whole knee joint specimens to determine cartilage composition, measured as T1ρ relaxation time. T1ρ MRI relaxation times refer to the proteoglycan density within cartilage.
Images taken at baseline and at Month 24.
Measured: Baseline, Month 24
Change From Baseline in T2 Relaxation Time
MRI exam of accelerated T2 conducted on whole knee joint specimens to determine cartilage composition, measured as T2 relaxation time. T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. Images taken at baseline and at Month 24.
Measured: Baseline, Month 24
Secondary outcomes (3)
Change From Baseline in Western Ontario and McMaster University OA Index (WOMAC) Score
The WOMAC is a 33-item self assessment of how participants feel about their knee and how well they can perform usual activities. The questionnaire contains 4 separately scored subscales - Symptoms; Stiffness; Pain and Function; and Daily Living. The total score is a percentage score from 0 to 100; lower scores represent less pain, less stiffness, and better physical function; higher scores indicate greater pain, greater stiffness, and worse physical function. A decrease in scores indicates participants' health improved during the observational period.
Measured: Baseline, Month 24
Change From Baseline in Knee Injury and OA Outcomes Score (KOOS)
Knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales - Pain; Other Symptoms; Function in daily living (ADL); Function in Sport and Recreation (Sport/Rec); and knee-related Quality of Life (QOL). The total score is a percentage score from 0 to 100; 0 represents extreme problems and 100 represents no problems. An increase in scores indicates participants' health improved during the observational period.
Measured: Baseline, Month 24
Change From Baseline in Physical Activity Scale for the Elderly (PASE) Scores
Self-assessment of multiple domains of activity in older adults. Questions evaluate both occupational and non-occupational knee bending, squatting and stair climbing. Total scores range from 0 to 400 or above and are quantified based on frequency values and weights for these activities. Higher scores indicate higher levels of physical activity. An increase in scores indicates physical activity increased during the observational period.
Measured: Baseline, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ravinder Regatte, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888119
- Sponsor's protocol ID
- 16-00918
- Status last verified
- Dec 2022
- First submitted
- 26 Aug 2016
- Last updated
- 27 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Biomarkers of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02888119
- Acronym / sponsor ID
- 16-00918
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2016 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Posted 27 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop, evaluate and translate highly accelerated imaging sequences (each protocol under 5 minutes) for in-vivo knee Osteoarthritis applications on a standard clinical 3T scanner using novel compression sensing and parallel imaging strategies.The overarching objective of the study is to establish a non-invasive imaging biomarker based on the development of rapid relaxation mapping with compressed sensing (CS) that will be clinically useful for assessment of early Osteoarthritis. A total of 90 subjects including 30 patients with high risk of developing knee osteoarthritis (OA), 30 patients with mild OA and 30 healthy controls will be accrued.
Detailed description
Current noninvasive imaging methods to evaluate knee joints include plain radiographs, computed tomography (CT), and clinical morphological magnetic resonance imaging (MRI) of joint structures. These techniques can only detect later-stage, macroscopic joint structural abnormalities that are irreversible and not amenable to early therapy. This study aims to develop highly accelerated imaging sequences for ex-vivo knee OA applications on a standard clinical 3T scanner using novel CS and parallel imaging (PI) strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Risk for Osteoarthritis | Active comparator | Device: PRISMA 3T MRI scanner (Siemens Medical Solutions)"High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions. |
| Mild Osteoarthritis | Active comparator | Device: PRISMA 3T MRI scanner (Siemens Medical Solutions) |
| Healthy Controls | Active comparator | Device: PRISMA 3T MRI scanner (Siemens Medical Solutions)Controls will be age/gender matched to patients within 2 years of age. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients in the HJD OA database, ages 40-75 with high risk of developing OA as defined by:
- Patients ages 40-75 with early OA as determined by KL scores 1-2
- Healthy controls in the HJD OA database (KL score 0, no knee pain, no meniscal or ligament tears)
Key exclusion criteria (5 listed)
- Contraindications for MRIs (e.g. pacemakers, ferromagnetic vascular clips, metal implants, claustrophobia, etc).
- Subjects with any joint disease (example: Rheumatoid or inflammatory arthritis) other than knee OA, corticosteroid injections within the previous 3 months, and history of avascular necrosis, Paget's disease of bone, Wilson's disease, gout, total knee replacement (or plan for replacement within next 24 months).
- Major co-morbidities such as diabetes, mellitus, cancer, congestive heart failure and chronic infectious diseases.
- Alignment interventions such as insoles and knee braces
- Vulnerable patients will not be recruited for this study
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 |
|---|---|---|
| PRISMA 3T MRI scanner (Siemens Medical Solutions)A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients. | Device | Healthy Controls, High Risk for Osteoarthritis, Mild Osteoarthritis |
Primary outcome
Change From Baseline in T1ρ Relaxation Time
Time frame: Baseline, Month 24
MRI exam of accelerated 3D-T1p conducted on whole knee joint specimens to determine cartilage composition, measured as T1ρ relaxation time. T1ρ MRI relaxation times refer to the proteoglycan density within cartilage. Images taken at baseline and at Month 24.
Change From Baseline in T2 Relaxation Time
Time frame: Baseline, Month 24
MRI exam of accelerated T2 conducted on whole knee joint specimens to determine cartilage composition, measured as T2 relaxation time. T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. Images taken at baseline and at Month 24.
3 secondary outcomes
Change From Baseline in Western Ontario and McMaster University OA Index (WOMAC) Score
Time frame: Baseline, Month 24
Change From Baseline in Knee Injury and OA Outcomes Score (KOOS)
Time frame: Baseline, Month 24
Change From Baseline in Physical Activity Scale for the Elderly (PASE) Scores
Time frame: Baseline, 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ravinder Regatte, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISMA 3T MRI scanner (Siemens Medical Solutions) in people with Osteoarthritis, run by NYU Langone Health 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 4 inclusion and 5 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 27 Dec 2022. 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?
Yes. Results are posted in the registry (first posted 27 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in T1ρ Relaxation Time (time frame: Baseline, Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2022.