An interventional study of Monovisc in Osteo Arthritis Shoulders, sponsored by Anika Therapeutics, Inc.. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Anika Therapeutics, Inc. · Not applicable, Interventional, and Treatment
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.
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.
Anika Therapeutics, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single injection of Monovisc into the Index Shoulder
Device: Monovisc
A chemically cross-linked sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe.
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.
Time frame: From Baseline to 6 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 Months
| Milestone | Monovisc |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
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.
| score on a scale | Monovisc |
|---|---|
| Numerical Rating Scale (NRS) Pain | -4.12 ± 2.21 |
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.
| score on a scale | Monovisc |
|---|---|
| Disabilities of Arm, Shoulder & Hand (DASH) Index | -36.22 ± 17.43 |
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.
| score on a scale | Monovisc |
|---|---|
| Patient Global Assessment (PGA) Score | -4.16 ± 2.36 |
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.
| Participants | Monovisc |
|---|---|
| The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | 23 |
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.
| Participants | Monovisc |
|---|---|
| Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol) | 21 |
Collected over Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 months).. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Monovisc | 0/25 (0%) | 0/25 (0%) | 5/25 (20%) |
| Event | Monovisc |
|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/25 |
| Joint SwellingMusculoskeletal and connective tissue disorders | 1/25 |
| HeadacheNervous system disorders | 1/25 |
| HypertensionVascular disorders | 1/25 |
| Age, Continuous(years) | Monovisc |
|---|---|
| Mean | 64.48 ± 9.02 |
| Sex: Female, Male(Participants) | Monovisc |
|---|---|
| Female | 14 |
| Male | 11 |
| Race (NIH/OMB)(Participants) | Monovisc |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 25 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Index Shoulder(Participants) | Monovisc |
|---|---|
| Right | 19 |
| Left | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2019 to primary completion in Feb 2021, 14 months.
Results were first posted in Jan 2025, 3 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Anika Therapeutics, Inc.