Imaging Biomarkers of Knee Osteoarthritis

NYU Langone Health

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: PRISMA 3T MRI scanner (Siemens Medical Solutions)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02888119

16-00918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

High Risk for Osteoarthritis

Active Comparator group

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.

Treatment:

Device: PRISMA 3T MRI scanner (Siemens Medical Solutions)

Mild Osteoarthritis

Active Comparator group

Treatment:

Device: PRISMA 3T MRI scanner (Siemens Medical Solutions)

Healthy Controls

Active Comparator group

Description:

Controls will be age/gender matched to patients within 2 years of age.

Treatment:

Device: PRISMA 3T MRI scanner (Siemens Medical Solutions)