Knee Osteoarthritis
Conditions
Keywords
Knee osteoarthritis, Hyaluronic acid, HA Injection, Steroid Injection, Knee injection
Brief summary
The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.
Detailed description
This study compared three groups of subjects. Group One received a single injection of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.
Interventions
DEVICEHyaluronic Acid and TH (Cingal®)
Injection into knee
DEVICEHyaluronic Acid (Monovisc®)
Injection into knee
DEVICESaline
Saline placebo packaged to look identical to comparator syringes. Injection into knee.
Sponsors
Anika Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and Outcomes Assessor were blinded to treatment
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2 * Subject has Kellgren-Lawrence (K-L) severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.
Exclusion criteria
* Subject received an intra-articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF). * Subject had an arthroscopy of either knee within 3 months of signing the informed consent form (ICF).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) | 12 Weeks | The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP) | 12 Weeks | The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT) | 12 Weeks | The change from baseline to 12 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (ITT population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 mm = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome. |
| Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT) | 1 Week | The change from baseline to 1 week in the Patient Global Assessment (PGA) comparing the Cingal® and Monovisc® arms (ITT population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) | 26 Weeks | Mean change in knee pain from baseline to 26 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group. The WOMAC Pain Score is a validated 100mm visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. |
| Evaluator Global Assessment Comparing Cingal® to Saline (ITT) | 12 Weeks | Mean change from baseline to 12 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome. |
| Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT) | 1 Week | Mean change from baseline to 1 week in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP) | 1 Week | Mean change in knee pain from baseline to 1 week as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT) | 1 Week | The change in knee pain from baseline to 1 week post treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. |
| Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP) | 12 Weeks | Mean change from baseline to 12 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (PP population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome. |
| Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP) | 1 Week | The post treatment Responder Rate comparing Cingal® and Monovisc® at 1 week is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index (PP population). The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. A higher percentage of subjects responding indicates a better outcome. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP) | 26 Weeks | Mean change in knee pain from baseline to 26 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (PP population). The WOMAC Pain Score is a validated 100mm visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. |
| Evaluator Global Assessment Comparing Cingal® to Saline (PP) | 12 Weeks | Mean change from baseline to 12 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome. |
| Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP). | 1 Week | Mean change from baseline to 1 week in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome. |
| Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP) | 3 Week | Mean change from baseline to 3 weeks in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome. |
| OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP) | 12 Weeks | The post treatment Responder Rate comparing Cingal® and Saline at 12 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index (PP population). The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. 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 two of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome. |
| OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT) | 12 Weeks | The post treatment Responder Rate at 12 weeks 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. 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 two of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome. |
Countries
Bulgaria, Canada, Czechia, Hungary, Poland
Participant flow
Recruitment details
594 potential subjects were screened for the study. 226 subjects were screen failures. 368 subjects were randomized into Cingal 13-01 and all received the study injection.
Pre-assignment details
The most common reason that subjects were excluded before being assigned to a study group (screen failures) was that enrollment target had been reached while subjects were in screening process. Other reasons for screen failure included radiological failures; Kellgren-Lawrence grade not meeting eligibility in the index or contralateral knee.
Participants by arm
| Arm | Count |
|---|---|
| Hyaluronic Acid and TH (Cingal®) Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 mL unit dose in a 5 mL glass syringe
Hyaluronic Acid and TH | 149 |
| Hyaluronic Acid (Monovisc®) Single injection of sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe
Hyaluronic Acid | 150 |
| Saline Single injection of 0.9% saline supplied as a 4 mL unit dose in a 5mL glass syringe
Saline: Saline placebo packaged to look identical to comparator syringes. | 69 |
| Total | 368 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 3 |
Baseline characteristics
| Characteristic | Hyaluronic Acid and TH (Cingal®) | Hyaluronic Acid (Monovisc®) | Saline | Total |
|---|---|---|---|---|
| Age, Continuous | 57.52 years STANDARD_DEVIATION 8.39 | 59.19 years STANDARD_DEVIATION 8.62 | 58.03 years STANDARD_DEVIATION 9.02 | 58.30 years STANDARD_DEVIATION 8.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 149 Participants | 149 Participants | 69 Participants | 367 Participants |
| Sex: Female, Male Female | 97 Participants | 99 Participants | 51 Participants | 247 Participants |
| Sex: Female, Male Male | 52 Participants | 51 Participants | 18 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 149 | 0 / 150 | 0 / 69 |
| other Total, other adverse events | 36 / 149 | 37 / 150 | 12 / 69 |
| serious Total, serious adverse events | 2 / 149 | 0 / 150 | 3 / 69 |
Outcome results
Primary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)
The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Time frame: 12 Weeks
Population: Intent To Treat (ITT) Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) | -40.2 score on a scale | Standard Error 1.7 |
| Hyaluronic Acid (Monovisc®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) | -36.1 score on a scale | Standard Error 1.6 |
| Saline | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) | -31.0 score on a scale | Standard Error 2.3 |
p-value: 0.0099ANOVA
Primary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP)
The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Time frame: 12 Weeks
Population: Per Protocol (PP) Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP) | -40.3 score on a scale | Standard Error 1.4 |
| Hyaluronic Acid (Monovisc®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP) | -35.9 score on a scale | Standard Error 1.62 |
| Saline | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP) | -32.2 score on a scale | Standard Error 2.2 |
p-value: 0.0029ANOVA
Secondary
Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP).
Mean change from baseline to 1 week in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Time frame: 1 Week
Population: Per Protocol (PP) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP). | -32.9 score on a scale | Standard Deviation 19.2 |
| Hyaluronic Acid (Monovisc®) | Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP). | -26.5 score on a scale | Standard Deviation 19.2 |
p-value: 0.0095ANOVA
Secondary
Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)
Mean change from baseline to 3 weeks in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Time frame: 3 Week
Population: Intent To Treat (ITT) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT) | -37.5 score on a scale | Standard Deviation 21 |
| Hyaluronic Acid (Monovisc®) | Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT) | -32.6 score on a scale | Standard Deviation 21.3 |
p-value: 0.0579ANOVA
Secondary
Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)
Mean change from baseline to 1 week in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Time frame: 1 Week
Population: Intent To Treat (ITT) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT) | -31.7 score on a scale | Standard Deviation 20.4 |
| Hyaluronic Acid (Monovisc®) | Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT) | -26.9 score on a scale | Standard Deviation 19.7 |
p-value: 0.044ANOVA
Secondary
Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP)
Mean change from baseline to 3 weeks in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Time frame: 3 Week
Population: Per Protocol (PP) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP) | -38.6 score on a scale | Standard Deviation 20.4 |
| Hyaluronic Acid (Monovisc®) | Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP) | -32.0 score on a scale | Standard Deviation 20.9 |
p-value: 0.0136ANOVA
Secondary
Evaluator Global Assessment Comparing Cingal® to Saline (ITT)
Mean change from baseline to 12 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Time frame: 12 Weeks
Population: Intent To Treat (ITT) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Evaluator Global Assessment Comparing Cingal® to Saline (ITT) | -36.8 score on a scale | Standard Error 1.5 |
| Hyaluronic Acid (Monovisc®) | Evaluator Global Assessment Comparing Cingal® to Saline (ITT) | -27.2 score on a scale | Standard Error 2.8 |
p-value: 0.003ANOVA
Secondary
Evaluator Global Assessment Comparing Cingal® to Saline (ITT)
Mean change from baseline to 26 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Time frame: 26 Weeks
Population: Intent To Treat (ITT) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Evaluator Global Assessment Comparing Cingal® to Saline (ITT) | -37.8 score on a scale | Standard Error 1.5 |
| Hyaluronic Acid (Monovisc®) | Evaluator Global Assessment Comparing Cingal® to Saline (ITT) | -28.7 score on a scale | Standard Error 2.8 |
p-value: 0.0046ANOVA
Secondary
Evaluator Global Assessment Comparing Cingal® to Saline (PP)
Mean change from baseline to 12 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Time frame: 12 Weeks
Population: Per Protocol (PP) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Evaluator Global Assessment Comparing Cingal® to Saline (PP) | -37.7 score on a scale | Standard Error 1.5 |
| Hyaluronic Acid (Monovisc®) | Evaluator Global Assessment Comparing Cingal® to Saline (PP) | -28.4 score on a scale | Standard Error 2.9 |
p-value: 0.0056ANOVA
Secondary
Evaluator Global Assessment Comparing Cingal® to Saline (PP)
Mean change from baseline to 26 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Time frame: 26 Weeks
Population: Per Protocol (PP) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Evaluator Global Assessment Comparing Cingal® to Saline (PP) | -39.1 score on a scale | Standard Error 1.5 |
| Hyaluronic Acid (Monovisc®) | Evaluator Global Assessment Comparing Cingal® to Saline (PP) | -29.8 score on a scale | Standard Error 2.9 |
p-value: 0.0059ANOVA
Secondary
OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT)
The post treatment Responder Rate at 12 weeks 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. 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 two of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome.
Time frame: 12 Weeks
Population: Intent To Treat (ITT) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT) | 92.0 percentage of subjects |
| Hyaluronic Acid (Monovisc®) | OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT) | 81.9 percentage of subjects |
p-value: 0.0141ANOVA
Secondary
OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP)
The post treatment Responder Rate comparing Cingal® and Saline at 12 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index (PP population). The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. 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 two of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome.
Time frame: 12 Weeks
Population: Per Protocol (PP) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP) | 92.8 percentage of subjects |
| Hyaluronic Acid (Monovisc®) | OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP) | 83.6 percentage of subjects |
p-value: 0.0227ANOVA
Secondary
Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)
Mean change from baseline to 3 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Monovisc® arms (ITT population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Time frame: 3 Weeks
Population: Intent To Treat (ITT) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT) | -37.7 score on a scale | Standard Deviation 23.9 |
| Hyaluronic Acid (Monovisc®) | Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT) | -32.1 score on a scale | Standard Deviation 23.7 |
p-value: 0.0323ANOVA
Secondary
Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)
The change from baseline to 1 week in the Patient Global Assessment (PGA) comparing the Cingal® and Monovisc® arms (ITT population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Time frame: 1 Week
Population: Intent To Treat (ITT) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT) | -32.8 score on a scale | Standard Deviation 23.3 |
| Hyaluronic Acid (Monovisc®) | Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT) | -24.7 score on a scale | Standard Deviation 22.6 |
p-value: 0.0533ANOVA
Secondary
Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)
Mean change from baseline to 3 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Monovisc® arms (PP population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Time frame: 3 Weeks
Population: Per Protocol (PP) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP) | -39.2 score on a scale | Standard Deviation 20.9 |
| Hyaluronic Acid (Monovisc®) | Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP) | -32.4 score on a scale | Standard Deviation 22.7 |
p-value: 0.0113ANOVA
Secondary
Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)
The post treatment Responder Rate comparing Cingal® and Monovisc® at 1 week is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index (PP population). The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. A higher percentage of subjects responding indicates a better outcome.
Time frame: 1 Week
Population: Per Protocol (PP) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP) | -33.7 score on a scale | Standard Deviation 22.3 |
| Hyaluronic Acid (Monovisc®) | Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP) | -27.1 score on a scale | Standard Deviation 22.2 |
p-value: 0.0148ANOVA
Secondary
Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)
Mean change from baseline to 26 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (ITT population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Time frame: 26 Weeks
Population: Intent To Treat (ITT) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT) | -37.0 score on a scale | Standard Error 1.5 |
| Hyaluronic Acid (Monovisc®) | Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT) | -26.3 score on a scale | Standard Error 2.5 |
p-value: 0.0005ANOVA
Secondary
Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)
The change from baseline to 12 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (ITT population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 mm = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Time frame: 12 Weeks
Population: Intent To Treat (ITT) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT) | -36.5 score on a scale | Standard Error 1.6 |
| Hyaluronic Acid (Monovisc®) | Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT) | -25.3 score on a scale | Standard Error 2.4 |
p-value: 0.0002ANOVA
Secondary
Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)
Mean change from baseline to 12 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (PP population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Time frame: 12 Weeks
Population: Per Protocol (PP) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP) | -37.8 score on a scale | Standard Error 1.5 |
| Hyaluronic Acid (Monovisc®) | Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP) | -26.0 score on a scale | Standard Error 2.6 |
p-value: 0.0002ANOVA
Secondary
Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)
Mean change from baseline to 26 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (PP population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today? The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Time frame: 26 Weeks
Population: Per Protocol (PP) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP) | -38.6 score on a scale | Standard Error 1.6 |
| Hyaluronic Acid (Monovisc®) | Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP) | -27.0 score on a scale | Standard Error 2.7 |
p-value: 0.0005ANOVA
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)
The change in knee pain from baseline to 3 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Time frame: 3 Weeks
Population: Intent To Treat (ITT) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT) | -40.1 score on a scale | Standard Deviation 20.1 |
| Hyaluronic Acid (Monovisc®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT) | -34.9 score on a scale | Standard Deviation 21.7 |
p-value: 0.0289ANOVA
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)
The change in knee pain from baseline to 1 week post treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Time frame: 1 Week
Population: Intent To Treat (ITT) Population comparing Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT) | -34.6 score on a scale | Standard Deviation 20.8 |
| Hyaluronic Acid (Monovisc®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT) | -29.6 score on a scale | Standard Deviation 21.4 |
p-value: 0.0367ANOVA
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)
Mean change in knee pain from baseline to 3 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Time frame: 3 Weeks
Population: Per Protocol (PP) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP) | -41.3 score on a scale | Standard Deviation 19.2 |
| Hyaluronic Acid (Monovisc®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP) | -35.3 score on a scale | Standard Deviation 22 |
p-value: 0.0154ANOVA
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)
Mean change in knee pain from baseline to 1 week as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Time frame: 1 Week
Population: Per Protocol (PP) Population to compare Cingal® group to Monovisc® group. Saline group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP) | -35.7 score on a scale | Standard Deviation 20.3 |
| Hyaluronic Acid (Monovisc®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP) | -29.2 score on a scale | Standard Deviation 21.7 |
p-value: 0.0087ANOVA
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)
Mean change in knee pain from baseline to 26 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group. The WOMAC Pain Score is a validated 100mm visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Time frame: 26 Weeks
Population: Intent To Treat (ITT) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) | -41.1 score on a scale | Standard Error 1.7 |
| Hyaluronic Acid (Monovisc®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) | -31.4 score on a scale | Standard Error 2.4 |
p-value: 0.0072ANOVA
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP)
Mean change in knee pain from baseline to 26 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (PP population). The WOMAC Pain Score is a validated 100mm visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Time frame: 26 Weeks
Population: Per Protocol (PP) Population to compare Cingal® group to Saline group. Monovisc® group is analyzed separately.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronic Acid and TH (Cingal®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP) | -41.2 score on a scale | Standard Error 1.4 |
| Hyaluronic Acid (Monovisc®) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP) | -32.4 score on a scale | Standard Error 2.3 |
p-value: 0.0016ANOVA