Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection
Status unconfirmed
Conditions studied: Knee Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT04093232
- Run by
- National Jewish Health
- People needed
- 50
- Starts
- 2019-01-01
- Expected to finish
- 2022-02-01
- Last updated by the study team
- 2021-03-03
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- national Jewish health — Denver, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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