Osteoarthritis AnkleNCT04204278
MONOVISC for Ankle Joint Pain Relief Due to Osteoarthritis
A study testing Monovisc in people with Osteoarthritis Ankle, run by Anika Therapeutics, Inc. at 4 sites in 2 countries.
Trial summary
The goal of this study is to demonstrate the clinical improvement and safety in patients treated with MONOVISC for ankle osteoarthritis. Specifically, this study will provide confirmation to the effectiveness and safety of MONOVISC at relieving ankle joint pain to 6 months post-treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Ankle
- What is being tested?
- Monovisc
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 11 Dec 2019to 30 Mar 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Body Mass Index (BMI) ≤ 35 kg/m2
- Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren-Lawrence grade I to III) to be treated with MONOVISC injection.
- Failed conservative treatment for joint osteoarthritis.
- NRS pain on walking ≥4 and ≤9 in the index joint.
- Subject must be willing to abstain from other treatments of the index joint for the duration of the study.
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- Subject is willing to discontinue all analgesics including NSAIDs, except acetaminophen/paracetamol, at least seven days before the treatment injection and through the completion of the study.
- Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams per day per the package insert) for the treatment of joint pain for the duration of the study. At least forty-eight hours prior to the Baseline Visit and each follow-up visit, the subject is willing to discontinue use of acetaminophen/paracetamol.
- Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products throughout the study, if taken prior to signing the informed consent form (ICF).
- Able and willing to provide signed informed consent.
Who cannot join
- History of hypersensitivity to any of the ingredients in the hyaluronan
- Infection or skin disease in the area of the injection site or index joint
- NRS pain on walking > 3 in the contralateral joint
- NRS pain on walking > 3 in the ipsilateral knee or hip
- Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either joint within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either joint during the course of this study.
- Known inflammatory or autoimmune disorders (including rheumatoid arthritis, gout), or other pre-existing medical conditions that, in the opinion of the investigator, could impact treatment of the index joint or affect the ability of the subject to accurately complete the study questionnaires and comply with the study requirements.
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- Subject is taking medications at the time of signing the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
- Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index joint only) corticosteroid prior 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index joint is allowed.
- Significant trauma to the index ankle within 26 weeks of screening
- Chronic use of narcotics or cannabis.
- Ligament instability or tear in index joint.
- Chronic impingement in the index joint requiring surgical treatment
- Diagnosis of fibromyalgia
- Diagnosis of osteonecrosis in index joint
- Subject has significant varus or valgus deformity greater than 10 degrees in either knee.
- Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable.
- Uncontrolled diabetes with HbA1c of >7%.
- Subject is a woman who is pregnant or breastfeeding at the Screening Visit or a woman of child bearing potential who refuses to use effective contraception during the course of the study.
- Subject is receiving or in litigation for worker's compensation.
- Otherwise determined by the investigator to be medically unsuitable for participation in this study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Poland3 sites
Nzoz Medi-Spatz
Gliwice
SPORTO
Lodz
Przychodnia Rodzinna na Sadowej
Torun
About this study
Official title: A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate (MONOVISC) to Provide Symptomatic Relief of Osteoarthritis of Ankle Joint
The goal of this study is to demonstrate the clinical improvement and safety in patients treated with MONOVISC for ankle osteoarthritis. Specifically, this study will provide confirmation to the effectiveness and safety of MONOVISC at relieving ankle joint pain to 6 months post-treatment.
Read the detailed description
Obtain real world, post market data to confirm the clinical improvement and safety in patients treated with a single injection of MONOVISC for the symptomatic relief of osteoarthritis in the ankle joint. The entire study duration from first subject in to last subject out will be approximately one and half years. The enrollment phase will be approximately 12 months with a follow-up phase of 6 months. Visits will be scheduled at screening, baseline, 1 month, 3 months and 6 months post treatment.
- Conditions
- Osteoarthritis Ankle
- Being tested
- Monovisc
- Keywords
- Hyaluronic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonoviscDevice
A chemically cross-linked sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe.
| Study group | Role | What they receive |
|---|---|---|
| Monovisc | Experimental | Single injection of MONOVISC into the index ankle joint Receives: Device: Monovisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) Pain on Walking
Mean Change in Numerical Rating Scale (NRS) Pain on Walking in the Index Ankle from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.
Measured: Baseline to 6 Months
Secondary outcomes (4)
American Orthopaedic Foot and Ankle Society (AOFAS) Score
Mean Change from baseline to 6 months in the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System Score. AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information in three parts to evaluate Pain, Function and Alignment. Patients report their pain (40 points), and function (50 points), and the evaluator assesses alignment (10 points). A total score is calculated by adding the three scores for final range from 0 (worst clinical status) to 100 points (best clinical status).
A positive increase in value for the change in AOFAS score indicates improvement. A larger positive value indicates a higher level of improvement, and a better outcome.
Measured: Baseline to 6 Months
Patient Global Assessment (PGA) Score
Mean change from baseline to 6 months in ankle pain post-treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) ankle is bothering them today. The PGA Score is a validated 11-point Likert scale from 0=No Pain to 10=Worst Pain.
A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.
Measured: Baseline to 6 Months
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function >50% and an absolute change >20 mm; or (2) improvement of >20% with an absolute change >10 mm in at least of the following three categories: pain, physical function, and patient's global assessment.
A higher percentage of subjects responding indicates a better outcome.
Measured: 6 Months
Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol)
The usage of Rescue Medication (RM) as based on the number of participants at 6 months post treatment that were NOT using acetaminophen/paracetamol RM for pain or discomfort.
A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start11 Dec 2019
- Primary completion26 Feb 2021
- Study completion30 Mar 2021
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 AnkleStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anika Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kara Mezger, Study director, Anika Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204278
- Sponsor's protocol ID
- MON 18-03
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2019
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate (MONOVISC) to Provide Symptomatic Relief of Osteoarthritis of Ankle Joint
- ClinicalTrials.gov ID
- NCT04204278
- Acronym / sponsor ID
- MON 18-03
- Conditions
- Osteoarthritis Ankle
- Keywords
- Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Anika Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to demonstrate the clinical improvement and safety in patients treated with MONOVISC for ankle osteoarthritis. Specifically, this study will provide confirmation to the effectiveness and safety of MONOVISC at relieving ankle joint pain to 6 months post-treatment.
Detailed description
Obtain real world, post market data to confirm the clinical improvement and safety in patients treated with a single injection of MONOVISC for the symptomatic relief of osteoarthritis in the ankle joint. The entire study duration from first subject in to last subject out will be approximately one and half years. The enrollment phase will be approximately 12 months with a follow-up phase of 6 months. Visits will be scheduled at screening, baseline, 1 month, 3 months and 6 months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monovisc | Experimental | Device: MonoviscSingle injection of MONOVISC into the index ankle joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 years or older
- Body Mass Index (BMI) ≤ 35 kg/m2
- Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren-Lawrence grade I to III) to be treated with MONOVISC injection.
- Failed conservative treatment for joint osteoarthritis.
- NRS pain on walking ≥4 and ≤9 in the index joint.
Key exclusion criteria (20 listed)
- History of hypersensitivity to any of the ingredients in the hyaluronan
- Infection or skin disease in the area of the injection site or index joint
- NRS pain on walking > 3 in the contralateral joint
- NRS pain on walking > 3 in the ipsilateral knee or hip
- Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either joint within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either joint during the course of this study.
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 |
|---|---|---|
| MonoviscA chemically cross-linked sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe. | Device | Monovisc |
Primary outcome
Numerical Rating Scale (NRS) Pain on Walking
Time frame: Baseline to 6 Months
Mean Change in Numerical Rating Scale (NRS) Pain on Walking in the Index Ankle from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.
4 secondary outcomes
American Orthopaedic Foot and Ankle Society (AOFAS) Score
Time frame: Baseline to 6 Months
Patient Global Assessment (PGA) Score
Time frame: Baseline to 6 Months
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Time frame: 6 Months
Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol)
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kara Mezger study director
Anika Therapeutics
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monovisc in people with Osteoarthritis Ankle, run by Anika Therapeutics, Inc. at 4 sites in 2 countries.
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 10 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: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Czechia. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2025). 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?
Numerical Rating Scale (NRS) Pain on Walking (time frame: Baseline to 6 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 28 Jan 2025.