- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02888119
Imaging Biomarkers of Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients in the HJD OA database, ages 40-75 with high risk of developing OA as defined by:
(i) 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High Risk for Osteoarthritis
"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.
|
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.
|
Active Comparator: Mild Osteoarthritis
|
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.
|
Active Comparator: Healthy Controls
Controls will be age/gender matched to patients within 2 years of age.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline, 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.
|
Baseline, Month 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Western Ontario and McMaster University OA Index (WOMAC) Score
Time Frame: Baseline, Month 24
|
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.
|
Baseline, Month 24
|
Change From Baseline in Knee Injury and OA Outcomes Score (KOOS)
Time Frame: Baseline, Month 24
|
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.
|
Baseline, Month 24
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Change From Baseline in Physical Activity Scale for the Elderly (PASE) Scores
Time Frame: Baseline, 24 Months
|
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.
|
Baseline, 24 Months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ravinder Regatte, MD, New York University Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-00918
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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