Imaging Biomarkers of Knee Osteoarthritis

NCT02888119 | Completed Results FDA Device

• 1 other identifier: 16-00918
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 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.

  Baseline, Month 24

Secondary Outcomes (3)

• Change From Baseline in Western Ontario and McMaster University OA Index (WOMAC) Score

  Baseline, Month 24

• Change From Baseline in Knee Injury and OA Outcomes Score (KOOS)

  Baseline, Month 24

• Change From Baseline in Physical Activity Scale for the Elderly (PASE) Scores

  Baseline, 24 Months

Study Arms (3)

High Risk for Osteoarthritis

ACTIVE COMPARATOR

"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.

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

Mild Osteoarthritis

ACTIVE COMPARATOR

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

Healthy Controls

ACTIVE COMPARATOR

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

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

Interventions

PRISMA 3T MRI scanner (Siemens Medical Solutions) DEVICE

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.

Healthy Controls; High Risk for Osteoarthritis; Mild Osteoarthritis

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Ravinder Regatte
• Organization: NYU Langone Health

Ravinder.Regatte@nyulangone.org

(212) 263-4857

Study Officials

• Ravinder Regatte, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 2, 2016
• Study Start: July 1, 2016
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: December 27, 2022
• Results First Posted: December 27, 2022

Record last verified: 2022-12

Locations

US (1)