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Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection

NCT04093232 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-03-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fidia Pharma USA Inc.

    collaborator INDUSTRY

  • National Jewish Health

    lead OTHER

Principal Investigators

  • Richard T Meehan, MD · Nnational Jewish health

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-01-01
Completion
2022-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04093232 on ClinicalTrials.gov