Osteo Arthritis ShouldersNCT04204265

MONOVISC for Shoulder Joint Pain Relief Due to Osteoarthritis

A study testing Monovisc in people with Osteo Arthritis Shoulders, run by Anika Therapeutics, Inc. at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 shoulder joint. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteo Arthritis Shoulders
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: 17 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) ≤ 45 kg/m2
Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren Lawrence grade I to III or Guyette grade I to III) to be treated with MONOVISC injection.
Failed conservative treatment for joint osteoarthritis.
NRS pain ≥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 > 3 in the contralateral joint
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.
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.

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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 shoulder within 26 weeks of screening
Chronic use of narcotics or cannabis.
Ligament instability or tear in index joint.
Diagnosis of fibromyalgia
Diagnosis of osteonecrosis in index joint
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.

Country

City, postcode or hospital

4 sites in 2 countries

Poland3 sites

Nzoz Medi-Spatz
Gliwice
SPORTO
Lodz
Przychodnia Rodzinna na Sadowej
Torun

Other trials in Poland

Czechia1 site

Krajská zdravotní, a.s.
Ústí nad Labem

Other trials in Czechia

About this study

Official title: A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate (MONOVISC) to Provide Symptomatic Relief of Osteoarthritis of Shoulder Joint

Read the detailed description

The goal of this study is to demonstrate the clinical improvement and safety in patients treated with MONOVISC for shoulder osteoarthritis. Specifically, this study will provide confirmation to the effectiveness and safety of MONOVISC at relieving shoulder joint pain to 6 months post-treatment.

Conditions: Osteo Arthritis Shoulders
Being tested: Monovisc
Keywords: Sodium Hyaluronate, 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 groups in NCT04204265
Study group	Role	What they receive
Monovisc	Other	Single injection of Monovisc into the Index Shoulder 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
Mean change in Numerical Rating Scale (NRS) Pain in the Index Shoulder 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: From Baseline to 6 Months

Secondary outcomes (4)

Disabilities of Arm, Shoulder & Hand (DASH) Index
Mean change in the Index Shoulder Disabilities of the Arm, Shoulder and Hand (DASH) Index from baseline to 6 months post injection. The DASH Index is a 30-item self-reported questionnaire on pain and function in which the response options are presented as 5-point Likert scales. Scores for each question range from 0=(no pain or disability) to 100=(most severe pain or disability) and are averaged to calculate the final DASH Index score.
A negative value for the change in DASH Index score indicates improvement.
A larger negative value indicates a higher level of improvement, and a better clinical outcome.
Measured: From Baseline to 6 Months
Patient Global Assessment (PGA) Score
Mean change from baseline to 6 months in Index Shoulder 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) shoulder 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: From 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 at 6 months as 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 to treatment indicates better clinical outcomes.
Measured: 6 Months
Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol)
The usage of Rescue Medication (RM) at 6 months post treatment as based on the number of participants 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.

17 Dec 201930 Mar 2021

First posted18 Dec 2019
Study start17 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 Osteo Arthritis ShouldersStudies 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04204265
Sponsor's protocol ID: MON 18-02
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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Clinical Evaluation of TrHCROSS® for Different Joints
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PRP for Glenohumeral Osteoarthritis
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Active, not recruitingObservational study
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
Arthroplasty, Replacement, Shoulder, Glenoid Cavity
RecruitingObservational study
Exactech Shoulder Post Market Clinical Follow-up Study
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All Osteo Arthritis Shoulders trials

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 Shoulder Joint
ClinicalTrials.gov ID: NCT04204265
Acronym / sponsor ID: MON 18-02
Conditions: Osteo Arthritis Shoulders
Keywords: Sodium Hyaluronate, Hyaluronic Acid
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Anika Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 17 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Monovisc	Other	Device: MonoviscSingle injection of Monovisc into the Index Shoulder

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) ≤ 45 kg/m2
Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren Lawrence grade I to III or Guyette grade I to III) to be treated with MONOVISC injection.
Failed conservative treatment for joint osteoarthritis.
NRS pain ≥4 and ≤9 in the index joint.

Key exclusion criteria (16 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 > 3 in the contralateral joint
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.

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
Time frame: From Baseline to 6 Months
Mean change in Numerical Rating Scale (NRS) Pain in the Index Shoulder 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

Disabilities of Arm, Shoulder & Hand (DASH) Index
Time frame: From Baseline to 6 Months
Patient Global Assessment (PGA) Score
Time frame: From 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

Results posted to the registry on 28 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Monovisc	25	25

Primary outcome: Numerical Rating Scale (NRS) Pain

Time frame: From Baseline to 6 Months. Mean (Standard Deviation). Unit: score on a scale

Measure	Monovisc n = 25
Value	-4.12 (2.21)

Monovisc: p <0.0001, t-test, 1 sided

Population analysed: Intent To Treat (ITT)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 months).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Monovisc	0 of 25 (0%)	5 of 25 (20%)	0 of 25

Limitations and caveats (from the sponsor): There were no limitations or caveats associated with the conduct of this trial.

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.

Related trials for Osteo Arthritis Shoulders

Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Clinical Evaluation of TrHCROSS® for Different Joints
Joint Osteoarthritis, Knee Osteoarthristis
RecruitingPhase 4
PRP for Glenohumeral Osteoarthritis
Shoulder Osteoarthritis
Active, not recruitingObservational study
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
Arthroplasty, Replacement, Shoulder, Glenoid Cavity
RecruitingObservational study
Exactech Shoulder Post Market Clinical Follow-up Study
Osteo Arthritis Shoulders, Osteonecrosis

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 Osteo Arthritis Shoulders, 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 16 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 (time frame: From Baseline to 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04204265.

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.