Apply to Trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

6 Participants Needed

Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

Recruiting at 1 trial location

Overseen ByMichael Keller

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ohio State University

Must not be taking: Immunosuppressants, Oral steroids

Disqualifiers: Rheumatoid arthritis, Cancer treatment, Smoking, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares three types of injections (Zilretta, Synvisc One, and Monovisc) for treating knee osteoarthritis. It targets people with knee osteoarthritis who need more relief than standard treatments provide. Zilretta helps by reducing inflammation, while Synvisc One and Monovisc help by lubricating and cushioning the knee joint. Cingal, a combination of sodium hyaluronate and triamcinolone hexacetonide, has shown greater pain reduction in knee osteoarthritis compared to sodium hyaluronate alone.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've had certain injections or treatments in the target knee recently, or if you're taking immunosuppressants or oral/IM steroids. Inhaled steroids for asthma/allergies are allowed.

Is the treatment generally safe for humans?

The research articles discuss the safety of zoledronic acid, which is not directly related to Monovisc, Synvisc-One, or Zilretta. Zoledronic acid can cause rare but serious eye inflammation (uveitis), which is treatable with prompt medical care.¹ ² ³ ⁴ ⁵

Who Is on the Research Team?

Michael Baria

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

Inclusion Criteria

Working knowledge of English language (to be able to complete all outcome scores)

Ability to attend all follow-up appointments

You have knee pain from osteoarthritis that has not improved after 6 weeks of physical therapy and trying different things like changing your activity level, losing weight, or taking over-the-counter pain medication like ibuprofen or acetaminophen.

See 5 more

Exclusion Criteria

You are currently taking medication to suppress your immune system.

You cannot have participated in any experimental drug or device study within the year before being screened for this trial.

Prior injection therapy: Steroid injection in target knee in the last 3 months

See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose injection of either Zilretta, Synvisc One, or Monovisc for knee osteoarthritis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual) at Baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

Monovisc
Synvisc-One
Zilretta

How Is the Trial Designed?

3Treatment groups

Active Control

Group I: 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 II: 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 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.

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Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

This case report describes the first instance of zoledronic acid-induced uveitis with macular edema occurring after a patient had tolerated long-term oral alendronate, suggesting that prior tolerance to one bisphosphonate does not guarantee safety with another.

The treatment for zoledronic acid-induced uveitis typically requires steroids, and rechallenging with bisphosphonates may not be contraindicated, as evidenced by cases where no additional uveitis occurred after rechallenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute bilateral uveitis and right macular edema induced by a single infusion of zoledronic acid for the treatment of postmenopausal osteoporosis as a substitution for oral alendronate: a case report.Tian, Y., Wang, R., Liu, L., et al.[2018]