An interventional study of Monovisc in Osteoarthritis, Hip, 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
Among 43 studies in Osteoarthritis, Hip with a site in Poland — 13 open to participants now, 13 under way, none of them phase 3. Osteoarthritis, Hip · Poland.
Among the 43 studies in Osteoarthritis, Hip with a site in Poland, this one is the 36th largest by enrollment of the 38 interventional ones, is one of 4 that started in 2019, is one of 20 with no phase, and was the 9th registered.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's enrollment of 25 is below the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →13 of the 43 studies in Osteoarthritis, Hip with a site in Poland are open now, in 1 country. Each count lists the studies.
Of the 87 Osteoarthritis, Hip studies recruiting now, 54 (62%) set no upper age limit and 7 (8%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →43 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 4 started in 2019.
Median enrollment 90 across the 38 interventional studies, 88 across the 5 observational. Of the 26 that completed or were terminated, 6 (23%) have results posted.
9 of 43 have an industry lead sponsor. The 10 most frequent:
Anika Therapeutics, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Anika Therapeutics, Inc. has 2 studies filed under Osteoarthritis, Hip — fewer than ten, so there is no comparison to draw.
9 of the studies in Osteoarthritis, Hip with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07327931Poznan University of Medical SciencesPENG Block Variants With Dexamethasone and Dexmedetomidine in Older Adults | 2026-12-30 |
| NCT07288983Poznan University of Medical SciencesPENG Block vs Suprainguinal FICB vs Lumbar ESPB for Analgesia After Hip Surgery | 2027-01-01 |
| NCT07327372Poznan University of Medical SciencesPENG Block With Dexmedetomidine in Older Adults | 2027-01-31 |
| NCT07327892Poznan University of Medical SciencesPENG Block vs PENG Plus Periarticular Injection vs Periarticular Injection in Older Adults | 2027-02-01 |
| NCT07584200Poznan University of Medical SciencesComparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty | 2027-03-31 |
Among the 43 studies in Osteoarthritis, Hip with a site in Poland, from their registry updates:
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 hip joint.
This is a prospective, post market clinical follow-up (PMCF) multi-center, open-label study to evaluate the residual risk of injections of MONOVISC for relief of pain in patients with a diagnosis of an osteoarthritic hip joint.
The subjects in this study will be patients with a diagnosis of osteoarthritic (OA) joint who the investigator determines are appropriate candidates for treatment with a viscoelastic injection of MONOVISC.
Up to 25 subjects will be enrolled at up to 20 investigational sites in the EU. Subject participation will last approximately 6 Months, with visits scheduled at Screening, Baseline, 1 month, 3 month and 6 months.
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 hip joint
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 on Walking
Mean Change in Numerical Rating Scale (NRS) Pain on Walking in the Index Hip 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 outcome following treatment.
Time frame: From Baseline to 6 Months
Lequesne Hip Index Score
Mean change in Lequesne Hip Index Score from baseline to 6 months post injection. The Lequesne Hip Index is a three-section patient questionnaire that evaluates (1) pain or discomfort, (2) maximum distance walked, and (3) activities of daily living with 0 = best results / normal scores, to scores \>14 = extremely severe, to a maximum index score of 24 points. A negative value for the change in Lequesne Hip Index indicates improvement. A larger negative value indicates a higher level of improvement, and a better outcome.
Time frame: From Baseline to 6 Months
Patient Global Assessment (PGA)
The change from baseline to 6 months in hip 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) hip is bothering them today . The PGA Score is a validated 11-point Likert scale ranged 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 indicates less pain, and a better clinical outcome.
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 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 clinical outcome.
Time frame: 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 acetominophen/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 on Walking in the Index Hip 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 outcome following treatment.
| score on a scale | Monovisc |
|---|---|
| Numerical Rating Scale (NRS) Pain on Walking | -3.68 ± 2.87 |
Mean change in Lequesne Hip Index Score from baseline to 6 months post injection. The Lequesne Hip Index is a three-section patient questionnaire that evaluates (1) pain or discomfort, (2) maximum distance walked, and (3) activities of daily living with 0 = best results / normal scores, to scores \>14 = extremely severe, to a maximum index score of 24 points. A negative value for the change in Lequesne Hip Index indicates improvement. A larger negative value indicates a higher level of improvement, and a better outcome.
| score on a scale | Monovisc |
|---|---|
| Lequesne Hip Index Score | -5.20 ± 3.46 |
The change from baseline to 6 months in hip 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) hip is bothering them today . The PGA Score is a validated 11-point Likert scale ranged 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 indicates less pain, and a better clinical outcome.
| score on a scale | Monovisc |
|---|---|
| Patient Global Assessment (PGA) | -3.52 ± 3.14 |
The post-treatment responder rate at 6 months 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 clinical outcome.
| Participants | Monovisc |
|---|---|
| The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | 20 |
The usage of Rescue Medication (RM) as based on the number of participants at 6 months post treatment that were NOT using acetominophen/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%) | 9/25 (36%) |
| Event | Monovisc |
|---|---|
| Viral pharyngitisInfections and infestations | 1/25 |
| NasopharyngitisInfections and infestations | 1/25 |
| Oral herpesInfections and infestations | 1/25 |
| SinusitisInfections and infestations | 1/25 |
| Diabetes insipidusEndocrine disorders | 1/25 |
| HypertensionVascular disorders | 1/25 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 1/25 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/25 |
| Back painMusculoskeletal and connective tissue disorders | 1/25 |
| MenorrhagiaReproductive system and breast disorders | 1/25 |
| Age, Continuous(years) | Monovisc |
|---|---|
| Mean | 57.72 ± 10.69 |
| Sex: Female, Male(Participants) | Monovisc |
|---|---|
| Female | 17 |
| Male | 8 |
| 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 Hip(Participants) | Monovisc |
|---|---|
| Right | 13 |
| Left | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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.
Of 226 interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 51. This study's 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Anika Therapeutics, Inc.