Osteoarthritis, Knee
Conditions
Brief summary
This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.
Detailed description
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.
Interventions
DRUGZilretta
Intra-articular injection to treat knee osteoarthritis
DRUGSynvisc-One 48 MG in 6 ML Prefilled Syringe
Intra-articular injection to treat knee osteoarthritis
DRUGMonovisc 88 MG Per 4 ML Prefilled Syringe
Intra-articular injection to treat knee osteoarthritis
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Patient Reported Outcome Questionnaire | Up to approximately 5 months | KOOS Pain evaluates short-term and long-term pain in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Patient Reported Outcome | Baseline until approximately 5 months | KOOS symptoms evaluates short-term and long-term symptoms in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee symptoms. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Patient Reported Outcome | Baseline until approximately 5 months | KOOS ADL evaluates short-term and long-term function in daily living in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to daily living activity. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) Patient Reported Outcome | Baseline until approximately 5 months | KOOS Sport/Rec evaluates short-term and long-term function in sports and recreation in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to sports or recreation activity. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life (QOL) Patient Reported Outcome | Baseline until to approximately 5 months | KOOS QOL evaluates short-term and long-term knee quality of life in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to quality of life. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Patient Reported Outcome | Baseline until approximately 5 months | KOOS Pain evaluates short-term and long-term pain in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee pain. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Baria
Ohio State University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 1 / 1 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 | 0 / 2 |
Outcome results
None listed