- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04093232
Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection
March 1, 2021 updated by: Richard Meehan, National Jewish Health
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
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mary Gill, MD
- Phone Number: 303 398 1443
- Email: gillm@njHealth.org
Study Contact Backup
- Name: richard T Meehan, MD
- Phone Number: 303 398-1475
- Email: meehanr@njHealth.org
Study Locations
-
-
Colorado
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Denver, Colorado, United States, 80206
- Recruiting
- National Jewish Health
-
Contact:
- Mary Gill, RN
- Phone Number: 303-398-1443
- Email: Gillm@njhealth.org
-
Contact:
- richard T Meehan, MD
- Phone Number: 303 398-1474
- Email: meehanr@njhealth.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with mild to moderate(on x rays) symptomatic knee osteoarthritis
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WOMAC scores (Western Ontario and McMaster University Osteoarthritis Index)
Time Frame: Change from baselinescore values to those over 12 months
|
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)
Time Frame: Change from baseline score values to those over 12 months
|
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
Time Frame: Change from baseline score values to those over 12 months
|
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
Time Frame: Change in distance walked from baseline to that distance walked over 12 months
|
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
Time Frame: Change in the depth of knee synovial fluid from baseline values to those at 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Synovial fluid and peripheral blood biomarkers
Time Frame: Change in the baseline levels of biomarkers in pg/ml to the levels 3 months after the first of 2 Hymovis injections
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard T Meehan, MD, Nnational Jewish health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
September 10, 2019
First Submitted That Met QC Criteria
September 16, 2019
First Posted (Actual)
September 17, 2019
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS 3179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Only de-identified SF cryopreserved samples may be made available to potential collaborators in the future.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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