Imaging Biomarkers of Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Imaging Biomarkers of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888119
• Other study ID #: 16-00918
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 13, 2021

Study information

• Verified date: December 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in T1? Relaxation Time	MRI exam of accelerated 3D-T1p conducted on whole knee joint specimens to determine cartilage composition, measured as T1? relaxation time. T1? MRI relaxation times refer to the proteoglycan density within cartilage.; Images taken at baseline and at Month 24.	Baseline, Month 24
Primary	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	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.	Baseline, Month 24
Secondary	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.	Baseline, Month 24
Secondary	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.	Baseline, 24 Months