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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monovisc | Experimental | Single injection of Monovisc into the index hip joint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monovisc | Device | A chemically cross-linked sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara Mezger | Anika Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krajská zdravotní, a.s. | Ústí nad Labem | Czechia | ||||
| Nzoz Medi-Spatz |
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Only one hip [Index Hip] of each participant was included in this study
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| ID | Title | Description |
|---|---|---|
| FG000 | Monovisc | Single injection of Monovisc into the index hip joint |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Monovisc | Single injection of Monovisc into the index hip joint |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent To Treat (ITT) | Posted | Mean | Standard Deviation | score on a scale | From Baseline to 6 Months |
|
|
Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 months).
The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions.
The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monovisc | Single injection of Monovisc into the index hip joint | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral pharyngitis | Infections and infestations | MedDRA v 23.1, 24.0 | Systematic Assessment |
There were no limitations or caveats associated with the conduct of this trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Mezger, Executive Director Clinical Affairs | Anika Therapeutics | 781.457.9000 | kmezger@anika.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2019 | Jun 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2021 | Jun 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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. | 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. | 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. | 6 Months |
| Gliwice |
| Poland |
| SPORTO | Lodz | Poland |
| Przychodnia Rodzinna na Sadowej | Torun | Poland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Index Hip | Count of Participants | Participants |
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| Secondary | 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. | Intent To Treat (ITT) | Posted | Mean | Standard Deviation | score on a scale | From Baseline to 6 Months |
|
|
|
|
| Secondary | 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. | Intent To Treat (ITT) | Posted | Mean | Standard Deviation | score on a scale | From Baseline to 6 Months |
|
|
|
|
| Secondary | 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. | Intent To Treat (ITT) | Posted | Count of Participants | Participants | 6 Months |
|
|
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| Secondary | 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. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| 25 |
| 0 |
| 25 |
| 9 |
| 25 |
| Nasopharyngitis | Infections and infestations | MedDRA v 22.1, 23.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v 22.1, 23.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA v 22.1, 23.0 | Systematic Assessment |
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| Diabetes insipidus | Endocrine disorders | MedDRA v 22.1, 23.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v 22.1, 23.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v 22.1, 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v 22.1, 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v 22.1, 23.0 | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA v 22.1, 23.0 | Systematic Assessment |
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INVESTIGATOR may publish the Data/Results with the consent of the SPONSOR if:
| D012216 |
| Rheumatic Diseases |