Osteoarthritis
Conditions
Keywords
Monovisc®, Hyaluronic Acid Gel, Injection, Knee
Brief summary
The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
Detailed description
This randomized, double-blind, placebo controlled prospective study will assess the safety and effectiveness of a single intra-articular injection of Monovisc® in providing symptomatic relief of pain caused by idiopathic osteoarthritis (OA) of the knee as compared to a placebo comparator injection of sterile saline.
Interventions
DEVICEMonovisc®
Intra-articular injection
OTHERSaline
0.9% Sterile Saline
Sponsors
Anika Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Male or Female * Age 35 to 75 years * Body Mass Index (BMI) 20 to 40 kg/m2 * Willing and able to provide informed consent * Willing to limit analgesic use to acetaminophen 7 days prior to and 12 weeks after injection * Not pregnant or lactating * Previous conservative treatment regimen for osteoarthritis (OA) * Diagnosis of idiopathic OA of the index knee * OA symptoms for \>= 6 months * Index knee Kellgren-Lawrence (K-L) grade of II or III * Index knee Baseline Summed WOMAC Pain Score \>= 200mm and \< 400mm after NSAID washout * Contralateral Knee K-L grade 0, I or II * Contralateral Knee Baseline WOMAC Pain Score \< 150mm after NSAID washout Main
Exclusion criteria
* Joint disorders which could interfere with treatment effectiveness * Joint disorders which could interfere with study assessments * Arthroscopy of either knee within 3 months of screening * Open surgery of index knee within 12 months of screening * Open surgery of contralateral knee within 3 months of screening * Injection of Hyaluronic Acid (HA) in either knee within 6 months of screening * Injection of steroid in index knee within 3 months of screening * Any pre-treatment contraindication for injection or aspiration of the index knee, including cutaneous infection, intra-articular infection, knee deformity or condition which may jeopardize sterility or delivery of injection * Synovial fluid aspirate volume \> 20 milliliters (mL) * Visual appearance of synovial fluid that contraindicates injection * Index knee range of motion \< 90 degrees * Subject participation in other research study within 30 days of screening * Subject unwilling to maintain active lifestyle, exercise program and body weight similar to that during 3 months prior to screening for duration of study * Unwilling to maintain constant dosage of oral glucosamine or chondroitin sulfate for duration of study, if applicable * Other medication or treatments that could interfere with study injection or assessments * Allergy to gram positive bacterial products or intolerance of acetaminophen * Active fibromyalgia * Peripheral neuropathy severe enough to interfere with evaluation of either knee * Vascular insufficiency severe enough to interfere with evaluation of the subject * Hemiparesis involving either lower extremity * Systemic bleeding disorder * Other conditions which may adversely affect the success of the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks | 12 Weeks | The primary endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved \>= a 40% improvement (reduction) in the WOMAC Pain Score and show at least 15 mm improvement (reduction) in the WOMAC Pain Score from baseline through 12 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. The primary endpoint uses the ITT population that has data available for both baseline and 12 week time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) | 12 Weeks | Comparison of the change of the Evaluator Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question Considering all the ways the osteoarthritis in the patient's index knee affect 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 (VAS 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. The endpoint uses the ITT population that has data available for both baseline and 12 week time points. |
| Patient Global Assessment Change From Baseline Through Week 12 (ITT) | 12 Weeks | Comparison of the change of the Patient Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers 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 Patient Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS 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. The endpoint uses the ITT population that has data available for both baseline and 12 week time points. |
| Range of Motion Change From Baseline Through Week 12 (ITT) | 12 Weeks | Comparison of the change of Range of Motion from baseline through Week 12 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 12 week time points. |
| WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) | 12 Weeks | This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated 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. The ITT population includes subjects with data at baseline and 12 Week time points. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Monovisc® Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection | 181 |
| Saline 0.9% Sterile Saline
Saline: 0.9% Sterile Saline | 184 |
| Total | 365 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | Other - Reason Not Provided | 5 | 3 |
| Overall Study | Use/Need of Con Therapy | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Saline | Total | Monovisc® |
|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 9.2 | 59.2 years STANDARD_DEVIATION 8.6 | 59.7 years STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 37 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) White | 163 Participants | 317 Participants | 154 Participants |
| Sex: Female, Male Female | 106 Participants | 213 Participants | 107 Participants |
| Sex: Female, Male Male | 78 Participants | 152 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 121 / 184 | 123 / 185 |
| serious Total, serious adverse events | 9 / 184 | 5 / 185 |
Outcome results
Primary
Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks
The primary endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved \>= a 40% improvement (reduction) in the WOMAC Pain Score and show at least 15 mm improvement (reduction) in the WOMAC Pain Score from baseline through 12 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. The primary endpoint uses the ITT population that has data available for both baseline and 12 week time points.
Time frame: 12 Weeks
Population: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Monovisc® | Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks | 62.57 Percentage of subjects |
| Saline | Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks | 56.14 Percentage of subjects |
p-value: 0.145Ordinal GEE Model
Secondary
Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)
Comparison of the change of the Evaluator Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question Considering all the ways the osteoarthritis in the patient's index knee affect 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 (VAS 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. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.
Time frame: 12 Weeks
Population: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monovisc® | Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) | Change from Baseline in Evaluator Global 12 weeks | -28.6 units on a scale | Standard Deviation 26.4 |
| Monovisc® | Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) | Baseline Evaluator Global | 59.1 units on a scale | Standard Deviation 15.5 |
| Monovisc® | Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) | 12 Week Evaluator Global | 30.4 units on a scale | Standard Deviation 23.5 |
| Saline | Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) | Change from Baseline in Evaluator Global 12 weeks | -26.4 units on a scale | Standard Deviation 26.4 |
| Saline | Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) | Baseline Evaluator Global | 58.9 units on a scale | Standard Deviation 14.6 |
| Saline | Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) | 12 Week Evaluator Global | 32.1 units on a scale | Standard Deviation 23.2 |
p-value: 0.5824Ordinal GEE Model
Secondary
Patient Global Assessment Change From Baseline Through Week 12 (ITT)
Comparison of the change of the Patient Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers 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 Patient Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS 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. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.
Time frame: 12 Weeks
Population: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monovisc® | Patient Global Assessment Change From Baseline Through Week 12 (ITT) | Change from Baseline in Patient Global 12 weeks | -28.8 units on a scale | Standard Deviation 30.8 |
| Monovisc® | Patient Global Assessment Change From Baseline Through Week 12 (ITT) | Baseline Patient Global | 62.9 units on a scale | Standard Deviation 17.5 |
| Monovisc® | Patient Global Assessment Change From Baseline Through Week 12 (ITT) | 12 Week Patient Global | 33.7 units on a scale | Standard Deviation 25 |
| Saline | Patient Global Assessment Change From Baseline Through Week 12 (ITT) | Change from Baseline in Patient Global 12 weeks | -28.9 units on a scale | Standard Deviation 27.7 |
| Saline | Patient Global Assessment Change From Baseline Through Week 12 (ITT) | Baseline Patient Global | 61.6 units on a scale | Standard Deviation 16.7 |
| Saline | Patient Global Assessment Change From Baseline Through Week 12 (ITT) | 12 Week Patient Global | 33.2 units on a scale | Standard Deviation 24.9 |
p-value: 0.9136Ordinal GEE Model
Secondary
Range of Motion Change From Baseline Through Week 12 (ITT)
Comparison of the change of Range of Motion from baseline through Week 12 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.
Time frame: 12 Weeks
Population: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monovisc® | Range of Motion Change From Baseline Through Week 12 (ITT) | Change from Baseline in Range of Motion 12 weeks | 1.5 degrees | Standard Deviation 14.9 |
| Monovisc® | Range of Motion Change From Baseline Through Week 12 (ITT) | Baseline Range of Motion | 116.3 degrees | Standard Deviation 16.4 |
| Monovisc® | Range of Motion Change From Baseline Through Week 12 (ITT) | 12 Week Range of Motion | 117.8 degrees | Standard Deviation 14.4 |
| Saline | Range of Motion Change From Baseline Through Week 12 (ITT) | Change from Baseline in Range of Motion 12 weeks | 4.6 degrees | Standard Deviation 14.4 |
| Saline | Range of Motion Change From Baseline Through Week 12 (ITT) | Baseline Range of Motion | 114.5 degrees | Standard Deviation 16 |
| Saline | Range of Motion Change From Baseline Through Week 12 (ITT) | 12 Week Range of Motion | 119.3 degrees | Standard Deviation 15.2 |
p-value: 0.1699Ordinal GEE Model
Secondary
WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)
This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated 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. The ITT population includes subjects with data at baseline and 12 Week time points.
Time frame: 12 Weeks
Population: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monovisc® | WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) | Change from Baseline in WOMAC Function 12 weeks | -24.1 units on a scale | Standard Deviation 26.1 |
| Monovisc® | WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) | Baseline WOMAC Function | 55.8 units on a scale | Standard Deviation 15.9 |
| Monovisc® | WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) | 12 Week WOMAC Function | 31.6 units on a scale | Standard Deviation 26.2 |
| Saline | WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) | Change from Baseline in WOMAC Function 12 weeks | -22.3 units on a scale | Standard Deviation 25.4 |
| Saline | WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) | Baseline WOMAC Function | 54.1 units on a scale | Standard Deviation 17.3 |
| Saline | WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) | 12 Week WOMAC Function | 31.7 units on a scale | Standard Deviation 25.3 |
p-value: 0.3238Ordinal GEE Model
Post Hoc
Evaluator Global Assessment Change From Baseline Through Week 26 (ITT)
Comparison of the change of the Evaluator Global Assessment from baseline through Week 26 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question Considering all the ways the osteoarthritis in the patient's index knee affect 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 patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 26 week time points.
Time frame: 26 Weeks
Population: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monovisc® | Evaluator Global Assessment Change From Baseline Through Week 26 (ITT) | Change from Baseline in Evaluator Global 26 weeks | -27.9 units on a scale | Standard Deviation 24.2 |
| Monovisc® | Evaluator Global Assessment Change From Baseline Through Week 26 (ITT) | Baseline Evaluator Global | 59.1 units on a scale | Standard Deviation 15.5 |
| Monovisc® | Evaluator Global Assessment Change From Baseline Through Week 26 (ITT) | 26 Week Evaluator Global | 31.9 units on a scale | Standard Deviation 22 |
| Saline | Evaluator Global Assessment Change From Baseline Through Week 26 (ITT) | Change from Baseline in Evaluator Global 26 weeks | -27.5 units on a scale | Standard Deviation 27.5 |
| Saline | Evaluator Global Assessment Change From Baseline Through Week 26 (ITT) | Baseline Evaluator Global | 58.9 units on a scale | Standard Deviation 14.6 |
| Saline | Evaluator Global Assessment Change From Baseline Through Week 26 (ITT) | 26 Week Evaluator Global | 30.9 units on a scale | Standard Deviation 22.9 |
p-value: 0.8206Ordinal GEE Model
Post Hoc
Patient Global Assessment Change From Baseline Through Week 26 (ITT)
Comparison of the change of the Patient Global Assessment from baseline through Week 26 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers 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 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. The endpoint uses the ITT population that has data available for both baseline and 26 week time points.
Time frame: 26 Weeks
Population: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monovisc® | Patient Global Assessment Change From Baseline Through Week 26 (ITT) | Change from Baseline in Patient Global 26 weeks | -28.5 units on a scale | Standard Deviation 27.9 |
| Monovisc® | Patient Global Assessment Change From Baseline Through Week 26 (ITT) | Baseline Patient Global | 62.9 units on a scale | Standard Deviation 17.5 |
| Monovisc® | Patient Global Assessment Change From Baseline Through Week 26 (ITT) | 26 Week Patient Global | 33.7 units on a scale | Standard Deviation 26 |
| Saline | Patient Global Assessment Change From Baseline Through Week 26 (ITT) | Change from Baseline in Patient Global 26 weeks | -28.6 units on a scale | Standard Deviation 27.2 |
| Saline | Patient Global Assessment Change From Baseline Through Week 26 (ITT) | Baseline Patient Global | 61.6 units on a scale | Standard Deviation 16.7 |
| Saline | Patient Global Assessment Change From Baseline Through Week 26 (ITT) | 26 Week Patient Global | 33.4 units on a scale | Standard Deviation 26.2 |
p-value: 0.9818Ordinal GEE Model
Post Hoc
Percentage Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=50% and 20 mm From Baseline Through 26 Weeks
This post-hoc endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved \>= a 50% improvement (reduction) in the WOMAC Pain Score and show at least 20 mm improvement (reduction) in the WOMAC Pain Score from baseline through 26 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. Reduction in the WOMAC Pain Score from baseline (e.g. a negative number) indicates improvement in pain. The primary endpoint uses the ITT population that has data available for both baseline and 26 week timepoints.
Time frame: 26 Weeks
Population: Intent-To-Treat population was defined as all randomized patients who received the study injection and had at least one post-injection visit; i.e: at least one visit after the Week 0 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Monovisc® | Percentage Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=50% and 20 mm From Baseline Through 26 Weeks | 44.38 Percentage of Participants |
| Saline | Percentage Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=50% and 20 mm From Baseline Through 26 Weeks | 34.12 Percentage of Participants |
p-value: 0.0427Ordinal GEE Model
Post Hoc
Range of Motion Change From Baseline Through Week 26 (ITT)
Comparison of the change of Range of Motion from baseline through Week 26 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 26 week time points.
Time frame: 26 Weeks
Population: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monovisc® | Range of Motion Change From Baseline Through Week 26 (ITT) | Change from Baseline in Range of Motion 26 Weeks | 1.0 degrees | Standard Deviation 14.9 |
| Monovisc® | Range of Motion Change From Baseline Through Week 26 (ITT) | Baseline Range of Motion | 116.3 degrees | Standard Deviation 16.4 |
| Monovisc® | Range of Motion Change From Baseline Through Week 26 (ITT) | 26 Week Range of Motion | 117.2 degrees | Standard Deviation 13.9 |
| Saline | Range of Motion Change From Baseline Through Week 26 (ITT) | Change from Baseline in Range of Motion 26 Weeks | 4.2 degrees | Standard Deviation 14.6 |
| Saline | Range of Motion Change From Baseline Through Week 26 (ITT) | Baseline Range of Motion | 114.5 degrees | Standard Deviation 16 |
| Saline | Range of Motion Change From Baseline Through Week 26 (ITT) | 26 Week Range of Motion | 118.8 degrees | Standard Deviation 14.2 |
p-value: 0.0542Ordinal GEE Model
Post Hoc
WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT)
This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 26 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated 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. The ITT population includes subjects with data at baseline and 26 Week time points.
Time frame: 26 Weeks
Population: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monovisc® | WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT) | Change from Baseline in WOMAC Function 26 weeks | -23.3 units on a scale | Standard Deviation 26 |
| Monovisc® | WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT) | Baseline WOMAC Function | 55.8 units on a scale | Standard Deviation 15.9 |
| Monovisc® | WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT) | 26 Week WOMAC Function | 32.5 units on a scale | Standard Deviation 24.8 |
| Saline | WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT) | Change from Baseline in WOMAC Function 26 weeks | -21.4 units on a scale | Standard Deviation 24.8 |
| Saline | WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT) | Baseline WOMAC Function | 54.1 units on a scale | Standard Deviation 17.3 |
| Saline | WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT) | 26 Week WOMAC Function | 33.1 units on a scale | Standard Deviation 25.2 |
p-value: 0.323Ordinal GEE Model