Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection

NCT04093232 | Unknown FDA Drug

• 1 other identifier: HS 3179
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• WOMAC scores (Western Ontario and McMaster University Osteoarthritis Index)

  Self reported numeric values: on pain, stiffness and 17 items of limitations on physical function scored as 0-5 (none, mild, moderate, severe or extreme)

  Change from baselinescore values to those over 12 months

• SF 36 scores (Quality of Life Questionnaire)

  Self reported numeric values based upon multiple domains; assessment of over all health, 0-4, (excellent , very good, good, fair and poor) and score compared to the prior year, 0-4, (much better, somewhat better, about the same, somewhat worse, much worse) and 10 functional daily living activity questions with score 0-2, (not at all limited, limited a little, and limited a lot) and 4 questions on patients health compared to others expectations or worsen or excellent health and if they more easily become sick 0-4, (false, mostly false, don't know, mostly true or definitely true. Higher scores indicate worse health and disability.

  Change from baseline score values to those over 12 months

• VAS (Visual analogue scale) score for self reported pain

  Self Reported patient assessment of pain from 0 I(no pain) on the left to 10 worst pain ever. The paint selects their value on a continuous 10 cm line. A higher numeric number on a 0 -10 scale selected indicates more severe pain.

  Change from baseline score values to those over 12 months

• 6 minute walking distance

  The measured distance in meters walked during a 6 minute supervised walk on level ground.

  Change in distance walked from baseline to that distance walked over 12 months

• Synovial fluid depth

  Ultrasound measurement in millimeters of the maximum SF depth during external pneumatic compression.

  Change in the depth of knee synovial fluid from baseline values to those at 12 months

Secondary Outcomes (1)

• Synovial fluid and peripheral blood biomarkers

  Change in the baseline levels of biomarkers in pg/ml to the levels 3 months after the first of 2 Hymovis injections

Interventions

Hymovis DRUG

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.

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mild to moderate(on x rays) symptomatic knee osteoarthritis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Jewish Health: lead
• Fidia Pharma USA Inc.: collaborator

Study Sites (1)

national Jewish health

Denver, Colorado, 80206, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Synovial fluid and peripheral blood samples will be cryopreserved for biomarkers of cartilage health and catabolic or anabolic protein measurements are to be correlated with clinical improvement post Hymovis injection

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Richard T Meehan, MD

  Nnational Jewish health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Gill, MD

CONTACT

303 398 1443; gillm@njHealth.org

richard T Meehan, MD

CONTACT

303 398-1475; meehanr@njHealth.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 17, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

US (1)