Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection

Knee Osteoarthritis Clinical Trial

Official title:

Alterations in Knee Synovial Fluid Biomarkers and Volume Following Hymovis Injections Using a Pneumatic Assistive Compression Device and Ultrasound Guided Arthrocentesis: Correlation With Clinical Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04093232
• Other study ID #: HS 3179
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2021
• Source: National Jewish Health
• Contact: Mary Gill, MD
• Phone: 303 398 1443
• Email: gillm[@]njHealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	national Jewish health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	Fidia Pharma USA Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Synovial fluid and peripheral blood biomarkers	54 separate cytokines ,chemokines and proteins which can impact cartilage health will be measured in the synovial fluid by ELISA and Luminex multiplex platforms on cryopreserved samples to determine the levels of these catabolic inflammatory or anabolic proteins which may impact cartilage health.	Change in the baseline levels of biomarkers in pg/ml to the levels 3 months after the first of 2 Hymovis injections