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Viscosupplementation Agent

Zilretta for Osteoarthritis

Phase 4
Waitlist Available
Led By Michael Baria
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 month, 6 month
Awards & highlights

Study Summary

This trial is testing whether Zilretta, Synvisc One, or Monovisc are effective for knee OA.

Eligible Conditions
  • Osteoarthritis of the Knee

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 month, 6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month, 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire
Secondary outcome measures
Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome
Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome
Knee
+2 more

Trial Design

3Treatment groups
Active Control
Group I: ZilrettaActive Control1 Intervention
Generic Name: Triamcinolone acetonide Zilretta is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management ofosteoarthritis pain of the knee. 5mL suspension of 32 mg of triamsinolone administered as a 1 dose parapatellar intra-articular injection.
Group II: Synvisc OneActive Control1 Intervention
Generic Name: Hylan G-F 20 Synvisc-One combines the three doses of SYNVISC (hylan G-F 20) which consists of hylan A (average molecular weight6,000,000 daltons) and hylan B hydrated gel in a buffered physiological sodium chloride solution, pH 7.2. Each 10 mL syringe of Synvisc-One combines the three 2-mL doses (16 mg each) of a complete SYNVISC treatment regimen (48 mg). Synvisc-One belongs to a class of drugs called Intra-Articular Agents; Rheumatologics, Other. 10mL of Hylan G-F 20 administered as a 1 dose parapatellar intra-articular injection.
Group III: MonoviscActive Control1 Intervention
Generic Name: Hyaluronan The Monovisc™ device is a proprietary high molecular weight hyaluronic acid (HA) viscosupplementation intended for the treatment of pain in patients with moderate osteoarthritis (OA) of the knee who have failed conservative non-pharmacological therapy and simple analgesics. The device is administered by a single injection via the para-patellar approach under sterile conditions. 4mL injection of Hyaluronan administered as a 1 dose parapatellar intra-articular injection.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
828 Previous Clinical Trials
505,745 Total Patients Enrolled
5 Trials studying Osteoarthritis
890 Patients Enrolled for Osteoarthritis
Michael BariaPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass those below the age of 25?

"According to the requirements for enrolment, only individuals between 25 and 85 years old are eligible. For those below 18 or above 65, 38 and 657 trials respectively are available."

Answered by AI

What is the current enrollment limit for this clinical trial?

"Affirmative. Clinicaltrials.gov evidence illustrates that this experiment is presently enlisting individuals. It was published on August 2nd 2022 and most recently modified on the 5th of the same month - seeking 165 participants from two medical centres."

Answered by AI

Is this research endeavor currently accepting participants?

"Affirmative. Clinicaltrials.gov has published data that this study is actively enrolling participants and was last updated on August 5th 2022; it initially appeared on the website in early August of 2020. The research project aims to secure 165 individuals across two medical centres."

Answered by AI

Who meets the eligibility criteria for participating in this research?

"This clinical trial is admitting 165 individuals aged 25 to 85 who have been diagnosed with osteoarthritis of the knee. Participants must also satisfy additional conditions, including a BMI less than 40, radiographic evidence that their target joint has grade 2-4 OA (Kellgren Lawrence Classification), ongoing pain in spite of physical therapy and/or activity modification, weight loss or NSAID use within the past 6 weeks, KOOS Pain Subscale score between 20 and 65, working knowledge of English language and ability to attend all follow up appointments."

Answered by AI

Has Monovisc been granted FDA authorization?

"Monovisc has been approved, so it was assigned a rating of 3 on our scale."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Jameson Crane Sports Medicine Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
Michael Baria 2022. "Trial Comparing Three Single Dose Injections for Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05492851.
~2 spots leftby Apr 2025
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