Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection

NCT ID: NCT04093232

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-02-01

Brief Summary

This NJH Investigator Initiated Study funded by Fidia will prospectively perform 2 ultrasound (US) guided knee aspirations in patients with knee osteoarthritis using a pneumatic compressive device (KneeTap ™) at baseline and at 3 months following 2 Hymovis® injections. Synovial fluid catabolic and anabolic proteins will be compared to those values in the peripheral blood and correlated with clinical outcome measurements at 3 ,6 and 12 months compared to baseline values; WOMAC, SF 36, visual analog pain scale, 6 minute walking distance and SF volumes quantitated by US.

Detailed Description

50 Subjects between 21-80 years with a BMI < 40 with mild to moderate knee osteoarthritis on x ray (KL grade II or III) will have a ultrasound guided arthrocentesis with an external pneumatic compression device (KneeTap) and if > 0.5 ml of synovial fluid is obtained they will received the first of 2 FDA approved Hymovis knee injections. A second ultrasound guided Hymovis intra-synovial space injection will be administered in one week with a repeat arthrocentesis in 3 months. Subjects will be compensated $ 50 for each of 4 of 5 study visits. Clinical outcome measures at study visits 1, 3 (3 months) 4 at (6 months) and 5 (12 months will include: VAS (Visual analog Global pain (1-10), SF -36 ,WOMAC questionnaires (Western Ontario and McMaster University Arthritis Index pain Scale), measured distance on 6 minute walking distance test and synovial fluid depth measured by ultrasound. The Synovial fluid biomarker panel will include values of over 45 separate cytokines,.chemokines and proteins from subjects pre vs post Hymovis injections and compared to values in the peripheral blood obtained simultaneously. SF biomarker analysis will be performed on cryopreserved samples using fluorescence multiplex bead based assays (Luminex) or by ELISA. All values as well as clinical outcome parameters will be entered into the REDCap system for statistical analysis

Conditions

Knee Osteoarthritis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Hymovis

All subjects will receive 2 ultrasound guided Hymovis injections and the goal of the study is to correlate responsiveness to subjects unique SF biomarker panel results before the first Hymovis injection and identify potential mechanism of action of those OA patients who receive the greatest benefit.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Mild to moderate knee osteoarthritis on x ray
• age 21-80

Exclusion Criteria

• pregnant
• BMI > 40
• history of systemic immune disorders
• knee arthroplasty with replacement
• knee infection or surgery within 1 year
• glucocorticoid injection within 3 months inability to ambulate for 6 minutes without walking assistive devices
• unable to provide informed consent
• patients with a clinical contra-indication for an arthrocentesis or adverse reaction to prior intra-articular lidocaine or HA injections.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fidia Pharma USA Inc.

INDUSTRY

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Richard Meehan

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard T Meehan, MD

Role: PRINCIPAL_INVESTIGATOR

Nnational Jewish health

Locations

national Jewish health

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Gill, MD

Role: CONTACT

gillm@njHealth.org

303 398 1443

richard T Meehan, MD

Role: CONTACT

meehanr@njHealth.org

303 398-1475

Facility Contacts

Mary Gill, RN

Role: primary

Gillm@njhealth.org

303-398-1443

richard T Meehan, MD

Role: backup

meehanr@njhealth.org

303 398-1474

Other Identifiers

HS 3179

Identifier Type: -

Identifier Source: org_study_id