Knee Osteoarthritis
Conditions
Keywords
Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide
Brief summary
Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
Detailed description
Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee
Interventions
Sponsors
Anika Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Study subjects and the Outcomes Assessor are blinded to the study treatment.
Intervention model description
In the 16-02 study, subjects were randomized in a 4:4:1 ratio into the Cingal, Monovisc (hyaluronic acid) or TH (triamcinolone hexacetonide) arm. The 17-02 study is a 39-week follow-up to the 16-02 study.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Only subjects that were enrolled and met the inclusion criteria for the Cingal 16-02 trial and signed the informed consent are eligible for Cingal 17-02 trial. 2. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.
Exclusion criteria
Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OMERACT-OARSI Responder Rate at 39 Weeks | 39 weeks | The post treatment Responder Rate at 39 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in WOMAC Physical Function Score at 39 Weeks | 39 Weeks | This endpoint compares the change of the WOMAC Physical Function Score from baseline to Week 39 between the Cingal and Triamcinolone Hexacetonide arms. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. |
| Change From Baseline in WOMAC Stiffness Score at 39 Weeks | 39 Weeks | The change from baseline in knee stiffness as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Stiffness Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of stiffness. A negative number for the change from baseline indicates improvement in knee stiffness. |
| Change From Baseline in Total WOMAC Score at 39 Weeks | 39 Weeks | The change from baseline as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The Total WOMAC Score is determined from the SUM of the scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Physical Function Score, resulting in a final range for Total Score from 0 mm to 240 mm. A higher Total WOMAC Score indicates a higher overall degree of pain, stiffness and functional limitations. A negative number for the change from baseline indicates improvement in the Total WOMAC Score. |
| Change From Baseline in WOMAC Pain Score at 39 Weeks | 39 Weeks | The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Pain Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher pain level. A negative number for the difference from baseline indicates improvement in pain. A greater negative difference from baseline indicates a better outcome. |
| Change From Baseline in Evaluator Global Assessment at 39 Weeks | 39 Weeks | Comparison of the change of the Evaluator Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Evaluator Global Assessment is done by the Blinded 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 0 to 100 mm visual analog scale, where a higher number means the Evaluator assesses that the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. |
| The Usage of Rescue Medication (Acetaminophen) at Week 39 | 39 Weeks | The usage of rescue medication (number of pills of acetominophen) at Week 39 weeks post treatment in the Cingal group compared to the Triamcinolone Hexacetonide group. |
| Change From Baseline in Patient Global Assessment at 39 Weeks | 39 Weeks | Comparison of the change of the Patient Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Patient Global Assessment is done by the subject, and answers the question Considering all the ways the osteoarthritis in your index knee bothers you, what is your assessment of how much your knee is bothering you today? The Patient Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. |
Countries
Hungary, Poland
Participant flow
Recruitment details
Subjects enrolled in Cingal 16-02 were given the option to enroll in Cingal 17-02 for a 39-week follow-up. 233 subjects in the Cingal arm (95%), 230 subjects in the Monovisc arm (93%), and 63 subjects in the Triamcinolone Hexacetonide arm (90%) elected to enroll in the extension study.
Pre-assignment details
No enrolled participants were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Cingal Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide | 233 |
| Monovisc Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid | 230 |
| Triamcinolone Hexacetonide (TH) Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide | 63 |
| Total | 526 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Cingal | Total | Triamcinolone Hexacetonide (TH) | Monovisc |
|---|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 8.8 | 57.9 years STANDARD_DEVIATION 8.8 | 59.2 years STANDARD_DEVIATION 8.4 | 57.7 years STANDARD_DEVIATION 8.9 |
| Baseline WOMAC Pain in Index Knee | 63.5 millimeters (mm) STANDARD_DEVIATION 11.1 | 63.7 millimeters (mm) STANDARD_DEVIATION 11.2 | 64.6 millimeters (mm) STANDARD_DEVIATION 10.9 | 63.7 millimeters (mm) STANDARD_DEVIATION 11.4 |
| 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 233 Participants | 526 Participants | 63 Participants | 230 Participants |
| Sex: Female, Male Female | 165 Participants | 361 Participants | 44 Participants | 152 Participants |
| Sex: Female, Male Male | 68 Participants | 165 Participants | 19 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 233 | 0 / 230 | 0 / 63 |
| other Total, other adverse events | 20 / 233 | 19 / 230 | 6 / 63 |
| serious Total, serious adverse events | 0 / 233 | 0 / 230 | 0 / 63 |
Outcome results
Primary
OMERACT-OARSI Responder Rate at 39 Weeks
The post treatment Responder Rate at 39 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: 39 weeks
Population: Intent to Treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cingal | OMERACT-OARSI Responder Rate at 39 Weeks | 91.2 Percentage of subjects |
| Monovisc | OMERACT-OARSI Responder Rate at 39 Weeks | 92.4 Percentage of subjects |
| Triamcinolone Hexacetonide (TH) | OMERACT-OARSI Responder Rate at 39 Weeks | 93.2 Percentage of subjects |
p-value: 0.8106ANOVA
Secondary
Change From Baseline in Evaluator Global Assessment at 39 Weeks
Comparison of the change of the Evaluator Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Evaluator Global Assessment is done by the Blinded 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 0 to 100 mm visual analog scale, where a higher number means the Evaluator assesses that the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment.
Time frame: 39 Weeks
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cingal | Change From Baseline in Evaluator Global Assessment at 39 Weeks | Baseline Evaluator Global in mm | 52.9 Millimeters (mm) | Standard Deviation 17.2 |
| Cingal | Change From Baseline in Evaluator Global Assessment at 39 Weeks | Change from Baseline in Evaluator Global 39 eeks | -37.1 Millimeters (mm) | Standard Deviation 21.3 |
| Cingal | Change From Baseline in Evaluator Global Assessment at 39 Weeks | 39 Week Evaluator Global in mm | 15.8 Millimeters (mm) | Standard Deviation 16.5 |
| Monovisc | Change From Baseline in Evaluator Global Assessment at 39 Weeks | Baseline Evaluator Global in mm | 52.3 Millimeters (mm) | Standard Deviation 17.7 |
| Monovisc | Change From Baseline in Evaluator Global Assessment at 39 Weeks | Change from Baseline in Evaluator Global 39 eeks | -37.7 Millimeters (mm) | Standard Deviation 19.9 |
| Monovisc | Change From Baseline in Evaluator Global Assessment at 39 Weeks | 39 Week Evaluator Global in mm | 14.6 Millimeters (mm) | Standard Deviation 16.5 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in Evaluator Global Assessment at 39 Weeks | Change from Baseline in Evaluator Global 39 eeks | -39.1 Millimeters (mm) | Standard Deviation 22.1 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in Evaluator Global Assessment at 39 Weeks | 39 Week Evaluator Global in mm | 17.4 Millimeters (mm) | Standard Deviation 15.6 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in Evaluator Global Assessment at 39 Weeks | Baseline Evaluator Global in mm | 56.6 Millimeters (mm) | Standard Deviation 18.1 |
p-value: 0.4551ANOVA
Secondary
Change From Baseline in Patient Global Assessment at 39 Weeks
Comparison of the change of the Patient Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Patient Global Assessment is done by the subject, and answers the question Considering all the ways the osteoarthritis in your index knee bothers you, what is your assessment of how much your knee is bothering you today? The Patient Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment.
Time frame: 39 Weeks
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cingal | Change From Baseline in Patient Global Assessment at 39 Weeks | 39 Week Patient Global in mm | 18.4 Millimeters (mm) | Standard Deviation 19.8 |
| Cingal | Change From Baseline in Patient Global Assessment at 39 Weeks | Baseline Patient Global in mm | 57.0 Millimeters (mm) | Standard Deviation 18.9 |
| Cingal | Change From Baseline in Patient Global Assessment at 39 Weeks | Change from Baseline in Patient Global 39 weeks | -38.6 Millimeters (mm) | Standard Deviation 25.4 |
| Monovisc | Change From Baseline in Patient Global Assessment at 39 Weeks | 39 Week Patient Global in mm | 17.8 Millimeters (mm) | Standard Deviation 19.4 |
| Monovisc | Change From Baseline in Patient Global Assessment at 39 Weeks | Change from Baseline in Patient Global 39 weeks | -38.2 Millimeters (mm) | Standard Deviation 22.8 |
| Monovisc | Change From Baseline in Patient Global Assessment at 39 Weeks | Baseline Patient Global in mm | 56.0 Millimeters (mm) | Standard Deviation 18.6 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in Patient Global Assessment at 39 Weeks | Baseline Patient Global in mm | 58.2 Millimeters (mm) | Standard Deviation 20.3 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in Patient Global Assessment at 39 Weeks | Change from Baseline in Patient Global 39 weeks | -36.7 Millimeters (mm) | Standard Deviation 28 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in Patient Global Assessment at 39 Weeks | 39 Week Patient Global in mm | 21.5 Millimeters (mm) | Standard Deviation 22.1 |
p-value: 0.5596ANOVA
Secondary
Change From Baseline in Total WOMAC Score at 39 Weeks
The change from baseline as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The Total WOMAC Score is determined from the SUM of the scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Physical Function Score, resulting in a final range for Total Score from 0 mm to 240 mm. A higher Total WOMAC Score indicates a higher overall degree of pain, stiffness and functional limitations. A negative number for the change from baseline indicates improvement in the Total WOMAC Score.
Time frame: 39 Weeks
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cingal | Change From Baseline in Total WOMAC Score at 39 Weeks | Baseline Total WOMAC in mm | 181.8 Millimeters (mm) | Standard Deviation 40.6 |
| Cingal | Change From Baseline in Total WOMAC Score at 39 Weeks | Change from Baseline in Total WOMAC 39 Weeks | -128.4 Millimeters (mm) | Standard Deviation 63.1 |
| Cingal | Change From Baseline in Total WOMAC Score at 39 Weeks | 39 Week Total WOMAC in mm | 53.4 Millimeters (mm) | Standard Deviation 58.1 |
| Monovisc | Change From Baseline in Total WOMAC Score at 39 Weeks | Baseline Total WOMAC in mm | 183.4 Millimeters (mm) | Standard Deviation 39.4 |
| Monovisc | Change From Baseline in Total WOMAC Score at 39 Weeks | Change from Baseline in Total WOMAC 39 Weeks | -132.6 Millimeters (mm) | Standard Deviation 56.6 |
| Monovisc | Change From Baseline in Total WOMAC Score at 39 Weeks | 39 Week Total WOMAC in mm | 50.8 Millimeters (mm) | Standard Deviation 54.6 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in Total WOMAC Score at 39 Weeks | Change from Baseline in Total WOMAC 39 Weeks | -122.7 Millimeters (mm) | Standard Deviation 62.2 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in Total WOMAC Score at 39 Weeks | 39 Week Total WOMAC in mm | 60.8 Millimeters (mm) | Standard Deviation 62.5 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in Total WOMAC Score at 39 Weeks | Baseline Total WOMAC in mm | 183.5 Millimeters (mm) | Standard Deviation 38.4 |
p-value: 0.4759ANOVA
Secondary
Change From Baseline in WOMAC Pain Score at 39 Weeks
The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Pain Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher pain level. A negative number for the difference from baseline indicates improvement in pain. A greater negative difference from baseline indicates a better outcome.
Time frame: 39 Weeks
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cingal | Change From Baseline in WOMAC Pain Score at 39 Weeks | Baseline WOMAC Pain in mm | 63.3 Millimeters (mm) | Standard Deviation 11 |
| Cingal | Change From Baseline in WOMAC Pain Score at 39 Weeks | Change from Baseline in WOMAC Pain 39 Weeks | -46.3 Millimeters (mm) | Standard Deviation 20.2 |
| Cingal | Change From Baseline in WOMAC Pain Score at 39 Weeks | 39 Week WOMAC Pain in mm | 17.0 Millimeters (mm) | Standard Deviation 19.3 |
| Monovisc | Change From Baseline in WOMAC Pain Score at 39 Weeks | Baseline WOMAC Pain in mm | 63.3 Millimeters (mm) | Standard Deviation 11.3 |
| Monovisc | Change From Baseline in WOMAC Pain Score at 39 Weeks | Change from Baseline in WOMAC Pain 39 Weeks | -47.2 Millimeters (mm) | Standard Deviation 18.6 |
| Monovisc | Change From Baseline in WOMAC Pain Score at 39 Weeks | 39 Week WOMAC Pain in mm | 16.0 Millimeters (mm) | Standard Deviation 18.6 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in WOMAC Pain Score at 39 Weeks | Change from Baseline in WOMAC Pain 39 Weeks | -43.6 Millimeters (mm) | Standard Deviation 21.4 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in WOMAC Pain Score at 39 Weeks | 39 Week WOMAC Pain in mm | 20.1 Millimeters (mm) | Standard Deviation 21.1 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in WOMAC Pain Score at 39 Weeks | Baseline WOMAC Pain in mm | 63.8 Millimeters (mm) | Standard Deviation 11.3 |
p-value: 0.3007ANOVA
Secondary
Change From Baseline in WOMAC Physical Function Score at 39 Weeks
This endpoint compares the change of the WOMAC Physical Function Score from baseline to Week 39 between the Cingal and Triamcinolone Hexacetonide arms. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function.
Time frame: 39 Weeks
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cingal | Change From Baseline in WOMAC Physical Function Score at 39 Weeks | Baseline WOMAC Function | 60.8 Millimeters (mm) | Standard Deviation 15.2 |
| Cingal | Change From Baseline in WOMAC Physical Function Score at 39 Weeks | Change from Baseline WOMAC Function 39 Weeks | -42.5 Millimeters (mm) | Standard Deviation 22.4 |
| Cingal | Change From Baseline in WOMAC Physical Function Score at 39 Weeks | 39 Week WOMAC Function | 18.4 Millimeters (mm) | Standard Deviation 19.8 |
| Monovisc | Change From Baseline in WOMAC Physical Function Score at 39 Weeks | Baseline WOMAC Function | 60.8 Millimeters (mm) | Standard Deviation 15.8 |
| Monovisc | Change From Baseline in WOMAC Physical Function Score at 39 Weeks | Change from Baseline WOMAC Function 39 Weeks | -43.5 Millimeters (mm) | Standard Deviation 20.7 |
| Monovisc | Change From Baseline in WOMAC Physical Function Score at 39 Weeks | 39 Week WOMAC Function | 17.3 Millimeters (mm) | Standard Deviation 18.6 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in WOMAC Physical Function Score at 39 Weeks | Change from Baseline WOMAC Function 39 Weeks | -41.1 Millimeters (mm) | Standard Deviation 22.5 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in WOMAC Physical Function Score at 39 Weeks | 39 Week WOMAC Function | 20.7 Millimeters (mm) | Standard Deviation 21.3 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in WOMAC Physical Function Score at 39 Weeks | Baseline WOMAC Function | 61.8 Millimeters (mm) | Standard Deviation 15.7 |
p-value: 0.6354ANOVA
Secondary
Change From Baseline in WOMAC Stiffness Score at 39 Weeks
The change from baseline in knee stiffness as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Stiffness Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of stiffness. A negative number for the change from baseline indicates improvement in knee stiffness.
Time frame: 39 Weeks
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cingal | Change From Baseline in WOMAC Stiffness Score at 39 Weeks | Change from Baseline in WOMAC Stiffness 39 Weeks | -39.8 Millimeters (mm) | Standard Deviation 24.4 |
| Cingal | Change From Baseline in WOMAC Stiffness Score at 39 Weeks | 39 Week WOMAC Stiffness in mm | 17.9 Millimeters (mm) | Standard Deviation 20 |
| Cingal | Change From Baseline in WOMAC Stiffness Score at 39 Weeks | Baseline WOMAC Stiffness in mm | 57.7 Millimeters (mm) | Standard Deviation 19.3 |
| Monovisc | Change From Baseline in WOMAC Stiffness Score at 39 Weeks | Baseline WOMAC Stiffness in mm | 59.2 Millimeters (mm) | Standard Deviation 18.1 |
| Monovisc | Change From Baseline in WOMAC Stiffness Score at 39 Weeks | 39 Week WOMAC Stiffness in mm | 17.2 Millimeters (mm) | Standard Deviation 18.6 |
| Monovisc | Change From Baseline in WOMAC Stiffness Score at 39 Weeks | Change from Baseline in WOMAC Stiffness 39 Weeks | -42.0 Millimeters (mm) | Standard Deviation 22.4 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in WOMAC Stiffness Score at 39 Weeks | 39 Week WOMAC Stiffness in mm | 19.9 Millimeters (mm) | Standard Deviation 21.9 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in WOMAC Stiffness Score at 39 Weeks | Change from Baseline in WOMAC Stiffness 39 Weeks | -38.0 Millimeters (mm) | Standard Deviation 24.9 |
| Triamcinolone Hexacetonide (TH) | Change From Baseline in WOMAC Stiffness Score at 39 Weeks | Baseline WOMAC Stiffness in mm | 57.9 Millimeters (mm) | Standard Deviation 17.6 |
p-value: 0.5754ANOVA
Secondary
The Usage of Rescue Medication (Acetaminophen) at Week 39
The usage of rescue medication (number of pills of acetominophen) at Week 39 weeks post treatment in the Cingal group compared to the Triamcinolone Hexacetonide group.
Time frame: 39 Weeks
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cingal | The Usage of Rescue Medication (Acetaminophen) at Week 39 | 7.9 Number of pills | Standard Deviation 39.5 |
| Monovisc | The Usage of Rescue Medication (Acetaminophen) at Week 39 | 6.0 Number of pills | Standard Deviation 18.7 |
| Triamcinolone Hexacetonide (TH) | The Usage of Rescue Medication (Acetaminophen) at Week 39 | 6.9 Number of pills | Standard Deviation 22.8 |
p-value: 0.7931ANOVA