A Double-blind, Randomized Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Ohio State University
- Enrollment
- 6
- Locations
- 4
- Primary Endpoint
- Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
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.
Intervention: Zilretta (Drug)
Monovisc
Generic Name: Hyaluronan The Monovisc™ 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.
Intervention: Monovisc 88 MG Per 4 ML Prefilled Syringe (Drug)
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.
Intervention: Synvisc-One 48 MG in 6 ML Prefilled Syringe (Drug)
Outcomes
Primary Outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire
Time Frame: 6 month
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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Patient Reported Outcome Questionnaire
Time Frame: 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 Outcomes
- Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome(Baseline, 3 month, 6 month)
- Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome(Baseline, 3 month, 6 month)
- Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome(Baseline, 3 month, 6 month)
- Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome(Baseline, 3 month, 6 month)
- Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome(Baseline, 3 month)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Patient Reported Outcome(Baseline until approximately 5 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Patient Reported Outcome(Baseline until approximately 5 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) Patient Reported Outcome(Baseline until approximately 5 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life (QOL) Patient Reported Outcome(Baseline until to approximately 5 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Patient Reported Outcome(Baseline until approximately 5 months)
Investigators
Michael Baria
Associate Professor
Ohio State University