N/A
Completed N=48
Imaging Biomarkers of Knee Osteoarthritis
Source: ClinicalTrials.gov NCT02888119 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Change From Baseline in T1ρ Relaxation Time — 2.1; 13.3 milliseconds
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.
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 | — |
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. Informational only — not medical advice.