N/A
N=48
Imaging Biomarkers of Knee Osteoarthritis
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02888119 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Change From Baseline in T1ρ Relaxation Time — 2.1; 13.3 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PRISMA 3T MRI scanner (Siemens Medical Solutions) (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in T1ρ Relaxation Time |
2.1; 13.3 | — |
| PRIMARY Change From Baseline in T2 Relaxation Time |
0.7; 11 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster University OA Index (WOMAC) Score |
5.4; 2.5 | — |
| SECONDARY Change From Baseline in Knee Injury and OA Outcomes Score (KOOS) |
6; 6.2 | — |
| SECONDARY Change From Baseline in Physical Activity Scale for the Elderly (PASE) Scores |
3.8; 3.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02888119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.