Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

Study Purpose

This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 25 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 25-85 years.
  • - BMI < 40.
  • - Diagnosis of unilateral knee OA.
  • - Radiographic evidence of OA of the target knee (Kellgren-Lawrence grades 2-4) - Continued OA pain in the target knee despite at least 6 weeks of: physical therapy and at least one of the following: activity modification (such as reducing impact on the knee), weight loss, and a 2 week trial of NSAID / acetaminophen.
  • - Knee Osteoarthritis Outcomes Score (KOOS)-Pain subscale 20-65.
  • - Working knowledge of English language (to be able to complete all outcome scores) - Ability to attend all follow-up appointments.

Exclusion Criteria:

  • - 3+ effusion of the target knee (stroke test grading system) - Prior injection therapy: - Steroid injection in target knee in the last 3 months.
  • - Viscosupplementation in target knee in the last 6 months.
  • - PRP in the target knee in the last 6 months.
  • - Cellular treatments in index knee (bone marrow, amniotic suspensions etc) 1 year.
  • - Participation in any experimental device or drug study within 1 year before screening visit.
  • - Oral or IM steroids in the last 3 months (Inhaled steroids used in the treatment of asthma/allergies are permitted) - Medical condition that may impact outcomes of procedure including: - Systemic inflammatory disorders that impact the joints like rheumatoid arthritis, lupus, etc.
  • - Undergoing current cancer treatment (other than non-melanoma skin malignancies) - Taking immunosuppressants.
  • - Previous cartilage repair procedure on the injured cartilage surface (ie, OATS, ACI, MFX) in the last 5 years.
  • - Previous surgery at the target knee within the past 1 year.
  • - Any degree of cognitive impairment.
  • - Symptomatic OA of any other joint in the lower limbs.
  • - Pregnancy, lactating, or intent to become pregnant during treatment period (Female participants will be asked if they are pregnant, lactating, or intend to become pregnant during treatment) - Gout, Pseudogout (including radiographic evidence of chondrocalcinosis) - History of infection or current infection at the affected joint.
- Smoking (Former smokers< 1 year from quit date)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05492851
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ohio State University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Baria
Principal Investigator Affiliation Ohio State University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Additional Details

Knee osteoarthritis (OA) is a leading cause of disability worldwide.1,2 Standard of care treatments for knee OA include activity modification, weight loss, therapeutic exercise and medications like non-steroidal anti-inflammatory drugs (NSAIDs). If these measures fail, injections like corticosteroids and hyaluronate (HA) can be helpful for pain control.3. The aforementioned injections have unique mechanisms of action. Steroid injections work through reducing joint inflammation, while HA works by lubricating and cushioning the joint. There are several varieties of steroids and HA injections that have been approved by the Food and Drug Administration for use in knee OA. Among these variations are extended-release triamcinolone (Zilretta), hylan GF-20 (synvisc one), and hyaluronan (monovisc). While each are FDA approved and commonly used in orthopedic and sports medicine clinics, they have never been directly compared in any study. Therefore, when selecting a treatment for a patient, it is largely based on provider preference, not clinical data. This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.

Arms & Interventions

Arms

Active Comparator: Zilretta

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.

Active Comparator: Synvisc One

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.

Active Comparator: Monovisc

Generic Name: Hyaluronan The Monoviscâ„¢ 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.

Interventions

Drug: - Zilretta

Intra-articular injection to treat knee osteoarthritis

Drug: - Synvisc-One 48 MG in 6 ML Prefilled Syringe

Intra-articular injection to treat knee osteoarthritis

Drug: - Monovisc 88 MG Per 4 ML Prefilled Syringe

Intra-articular injection to treat knee osteoarthritis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Jameson Crane Sports Medicine Institute, Columbus, Ohio

Status

Recruiting

Address

Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202

Site Contact

Michael K

[email protected]

614-293-2410

Ohio State Outpatient Lewis Center, Lewis Center, Ohio

Status

Recruiting

Address

Ohio State Outpatient Lewis Center

Lewis Center, Ohio, 43035

Site Contact

Michael Keller

[email protected]

614-293-2410