Overview

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)