Clinical trial NCT04093232: Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Fidia Pharma USA Inc.
First posted: 2019-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mild to moderate(on x rays) symptomatic knee osteoarthritis

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

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.

Primary outcomes:
measure: WOMAC scores (Western Ontario and McMaster University Osteoarthritis Index)
timeFrame: Change from baselinescore values to those over 12 months
measure: SF 36 scores (Quality of Life Questionnaire)
timeFrame: Change from baseline score values to those over 12 months
measure: VAS (Visual analogue scale) score for self reported pain
timeFrame: Change from baseline score values to those over 12 months
measure: 6 minute walking distance
timeFrame: Change in distance walked from baseline to that distance walked over 12 months
measure: Synovial fluid depth
timeFrame: Change in the depth of knee synovial fluid from baseline values to those at 12 months
Secondary outcomes:
measure: Synovial fluid and peripheral blood biomarkers
timeFrame: Change in the baseline levels of biomarkers in pg/ml to the levels 3 months after the first of 2 Hymovis injections
Other outcomes:
Locations:
city: Denver
country: United States
facility: national Jewish health
state: Colorado
Study officials:
affiliation: Nnational Jewish health
name: Richard T Meehan, MD
role: PRINCIPAL_INVESTIGATOR
References: