Clinical trial
A Double-blind, Randomized Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
Name
2022H0168
Description
This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.
Trial arms
Trial start
2022-08-02
Estimated PCD
2023-01-11
Trial end
2023-01-11
Status
Terminated
Phase
Early phase I
Treatment
Zilretta
Intra-articular injection to treat knee osteoarthritis
Arms:
Zilretta
Synvisc-One 48 MG in 6 ML Prefilled Syringe
Intra-articular injection to treat knee osteoarthritis
Arms:
Synvisc One
Monovisc 88 MG Per 4 ML Prefilled Syringe
Intra-articular injection to treat knee osteoarthritis
Arms:
Monovisc
Size
6
Primary endpoint
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire
6 month
Eligibility 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}
Updated at
2023-04-10
1 organization
3 products
2 indications
Organization
Ohio State UniversityProduct
ZilrettaIndication
OsteoarthritisIndication
KneeProduct
Synvisc-OneProduct
Monovisc