Back to resultsImaging Biomarkers of Knee Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRISMA 3T MRI scanner (Siemens Medical Solutions)
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
High Risk for Osteoarthritis
Mild Osteoarthritis
Healthy Controls
Arm Description
"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.
Controls will be age/gender matched to patients within 2 years of age.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02888119
First Posted
August 26, 2016
Last Updated
December 2, 2022
Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02888119
Brief Title
Imaging Biomarkers of Knee Osteoarthritis
Official Title
Imaging Biomarkers of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Risk for Osteoarthritis
Arm Type
Active Comparator
Arm Description
"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.
Arm Title
Mild Osteoarthritis
Arm Type
Active Comparator
Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
Controls will be age/gender matched to patients within 2 years of age.
Intervention Type
Device
Intervention Name(s)
PRISMA 3T MRI scanner (Siemens Medical Solutions)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in T1ρ Relaxation Time
Description
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.
Time Frame
Baseline, Month 24
Title
Change From Baseline in T2 Relaxation Time
Description
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.
Time Frame
Baseline, Month 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster University OA Index (WOMAC) Score
Description
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.
Time Frame
Baseline, Month 24
Title
Change From Baseline in Knee Injury and OA Outcomes Score (KOOS)
Description
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.
Time Frame
Baseline, Month 24
Title
Change From Baseline in Physical Activity Scale for the Elderly (PASE) Scores
Description
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.
Time Frame
Baseline, 24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravinder Regatte, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Imaging Biomarkers of Knee Osteoarthritis
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