Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-31 @ 5:42 AM
Study NCT ID:
NCT04093232
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2019-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection
Sponsor:
National Jewish Health
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: