Injections for Knee Osteoarthritis

No longer recruiting at 1 trial location

Overseen By Michael 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 Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of three injections—Zilretta, Synvisc-One, and Monovisc—in treating knee osteoarthritis (OA). Each treatment is administered as a single-dose injection to determine which best reduces pain and improves knee function. It suits those who have struggled with knee OA pain despite trying physical therapy, activity changes, or common pain relievers for at least six weeks and who haven't had recent knee injections. Participants must have one affected knee and be able to attend follow-up appointments. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, offering participants a chance to benefit from established therapies.

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.

What is the safety track record for these treatments?

Research shows that the treatments compared in this trial—Zilretta, Synvisc-One, and Monovisc—have been studied for safety in people with knee osteoarthritis.

For Synvisc-One, studies found that the most common side effects are temporary pain, swelling, or fluid buildup in the injected knee. These effects are usually mild and short-lived.

Zilretta has also undergone testing in several studies. The most common side effects include joint pain, headaches, and swelling, similar to those from other knee pain treatments.

Monovisc is another treatment option with a well-known safety record. The most common side effect is temporary discomfort at the injection site, which typically resolves on its own.

All three treatments have shown to be generally well-tolerated in past studies, with side effects mostly mild and temporary. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for knee osteoarthritis because they each offer unique benefits over traditional care options like NSAIDs or corticosteroid injections. Monovisc stands out as a single-dose, high molecular weight hyaluronic acid injection, which could potentially reduce pain and improve mobility without the need for multiple doses. Synvisc-One combines three doses of hylan G-F 20 into one, which might enhance the ease of treatment while maintaining efficacy. Zilretta is an extended-release corticosteroid injection that aims to provide prolonged pain relief with just one application, avoiding frequent injections. These features promise more convenient and potentially more effective management of knee osteoarthritis.

What evidence suggests that this trial's treatments could be effective for knee OA?

Research shows that Synvisc-One, a treatment in this trial, can significantly reduce knee pain from osteoarthritis for up to six months. Patients often move more easily and need less pain medication. Zilretta, another treatment option, is an extended-release steroid that offers quick and lasting relief, with many patients experiencing little to no pain just one week after treatment. Monovisc, also under study, is a hyaluronic acid injection that effectively reduces osteoarthritis pain, with benefits often lasting up to six months. This treatment can improve joint function by restoring the knee's natural fluid. Each of these options has proven effective in relieving knee osteoarthritis pain. ^{3 5 6 7 8}

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.

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

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?

Group I: Synvisc One Active Control 1 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: Zilretta Active Control 1 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: Monovisc Active Control 1 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.

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30159738/

Single intra-articular injection of lightly cross-linked ... The primary effectiveness endpoint was a 50% improvement and ≥ 20 mm improvement from baseline in the WOMAC pain through 26 weeks. Secondary outcome measures ...

2. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/25549-a-comprehensive-review-of-viscosupplementation-in-osteoarthritis-of-the-knee

A Comprehensive Review of Viscosupplementation in ... also found that Monovisc was safe and effective at providing clinically significant pain improvement within 2 weeks.

3. monovisc.ca monovisc.ca/en/professionals

Monovisc® for healthcare professionals Effective OA pain relief for up to six months, with a proven onset at two weeks* · 99% of Monovisc® patients experienced sustained OA pain reduction as measured ...

4. bmj.com bmj.com/content/378/bmj-2022-069722

Viscosupplementation for knee osteoarthritis: systematic ... Strong conclusive evidence indicates that viscosupplementation leads to a small reduction in knee osteoarthritis pain compared with placebo.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11597132/

Less Pain with Intra-Articular Hyaluronic Acid Injections for ... HA injections can improve joint function and reduce symptoms in mild to moderate OA by restoring synovial fluid properties. However, in advanced ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf9/P090031b.pdf

Monovisc - accessdata.fda.gov The study assessed the safety and effectiveness of three injections of ORTHOVISC® to treat knee pain in patients with bilateral knee.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3526887/

Long term safety, efficacy, and patient acceptability of ... The safety profile of intraarticular HA injections for painful knee osteoarthritis is well established, with the most common adverse effect being a self-limited ...

8. anika.com anika.com/medical/products/monovisc/

Monovisc - Single Injection Hyaluronic Acid ... Monovisc is a single injection viscosupplement to treat knee joint pain due to osteoarthritis ... FDA Monovisc Summary of Safety and Effectiveness Data 2014 ...