Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Hylan

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)