Osteoarthritis, KneePhase 4NCT05492851
Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
A Phase 4 study testing Zilretta, Synvisc-One 48 MG in 6 ML Prefilled Syringe and Monovisc 88 MG Per 4 ML Prefilled Syringe in people with Osteoarthritis, Knee, run by Ohio State University at 2 sites in United States.
Trial summary
This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Zilretta, Synvisc-One 48 MG in 6 ML Prefilled Syringe and Monovisc 88 MG Per 4 ML Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Aug 2022to 11 Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202
Ohio State Outpatient Lewis Center
Lewis Center, Ohio, 43035
About this study
Official title: A Double-blind, Randomized Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Zilretta, Synvisc-One 48 MG in 6 ML Prefilled Syringe, Monovisc 88 MG Per 4 ML Prefilled Syringe
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZilrettaDrug
Intra-articular injection to treat knee osteoarthritis
Synvisc-One 48 MG in 6 ML Prefilled SyringeDrug
Intra-articular injection to treat knee osteoarthritis
Monovisc 88 MG Per 4 ML Prefilled SyringeDrug
Intra-articular injection to treat knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Zilretta | Active comparator | 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. Receives: Drug: Zilretta |
| Synvisc One | Active comparator | 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. Receives: Drug: Synvisc-One 48 MG in 6 ML Prefilled Syringe |
| Monovisc | Active comparator | 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. Receives: Drug: Monovisc 88 MG Per 4 ML Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Patient Reported Outcome Questionnaire
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.
Measured: Up to approximately 5 months
Secondary outcomes (5)
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Patient Reported Outcome
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.
Measured: Baseline until approximately 5 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Patient Reported Outcome
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.
Measured: Baseline until approximately 5 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) Patient Reported Outcome
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.
Measured: Baseline until approximately 5 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life (QOL) Patient Reported Outcome
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.
Measured: Baseline until to approximately 5 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Patient Reported Outcome
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.
Measured: Baseline until approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start2 Aug 2022
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Why it stopped: The study has only enrolled 6 subjects in 6 months since study initiation. Potential participants are unwilling to participate in the study due to the randomziation and blinding. Both aspects are needed to ensure a robust comparison between groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Baria, Ohio State University
- Investigators
- Michael Baria, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492851
- Sponsor's protocol ID
- 2022H0168
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2022
- Last updated
- 17 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05492851
- Acronym / sponsor ID
- 2022H0168
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has only enrolled 6 subjects in 6 months since study initiation. Potential participants are unwilling to participate in the study due to the randomziation and blinding. Both aspects are needed to ensure a robust comparison between groups.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Posted 17 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zilretta | Active comparator | Drug: ZilrettaGeneric 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. |
| Synvisc One | Active comparator | Drug: Synvisc-One 48 MG in 6 ML Prefilled SyringeGeneric 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. |
| Monovisc | Active comparator | Drug: Monovisc 88 MG Per 4 ML Prefilled SyringeGeneric 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. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 3+ effusion of the target knee (stroke test grading system)
- Prior injection therapy:
- 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:
- Taking immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZilrettaIntra-articular injection to treat knee osteoarthritis | Drug | Zilretta |
| Synvisc-One 48 MG in 6 ML Prefilled SyringeIntra-articular injection to treat knee osteoarthritis | Drug | Synvisc One |
| Monovisc 88 MG Per 4 ML Prefilled SyringeIntra-articular injection to treat knee osteoarthritis | Drug | Monovisc |
Primary outcome
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.
5 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Patient Reported Outcome
Time frame: Baseline until approximately 5 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Patient Reported Outcome
Time frame: Baseline until approximately 5 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) Patient Reported Outcome
Time frame: Baseline until approximately 5 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life (QOL) Patient Reported Outcome
Time frame: Baseline until to approximately 5 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Patient Reported Outcome
Time frame: Baseline until approximately 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IDP will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Baria principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zilretta, Synvisc-One 48 MG in 6 ML Prefilled Syringe and Monovisc 88 MG Per 4 ML Prefilled Syringe in people with Osteoarthritis, Knee, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Patient Reported Outcome Questionnaire (time frame: Up to approximately 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.