Osteoarthritis, Knee, Musculoskeletal Diseases
Conditions
Keywords
Osteoarthritis of the knee, Musculoskeletal
Brief summary
This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with Synvisc after the week 26 visit.
Detailed description
The trial included an initial 26 week treatment with 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control) followed by a 4 week repeat treatment of Synvisc.
Interventions
DEVICEhylan G-F 20
Single injection of 6 mL of hylan G-F 20 (Synvisc).
Single injection of 6 mL phosphate buffered saline.
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with documented diagnosis of primary osteoarthritis (OA) of the target knee made at least 3 months prior to Screening, * Has radiographic evidence of OA in the tibio-femoral compartment of the target, knee with at least 1 definite osteophyte and a measureable joint space, as diagnosed by standard X-rays taken not longer than 3 months prior to Screening, and before any baseline assessment, * Has continued target knee pain despite conservative treatment (e.g. weight reduction, physical therapy, analgesics), * Has pain in the target knee as demonstrated by a score of 2 or 3 on the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale , * Has a mean score of 1.5 to 3.5 on the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale. * Inclusion Criteria for Repeat Phase: Must have no major safety concerns during the first course of treatment as assessed by the Investigator; Must have a WOMAC LK 3.1 A score of at least 1.
Exclusion criteria
* Has modified Kellgren-Lawrence Numerical Grading System of grade IV in the patello-femoral compartment of the target knee confirmed by standard X-rays taken not longer than 3 months prior to Screening, and before any baseline assessment, * Has clinically apparent tense effusion of the target knee, * Has had viscosupplementation in any joint including the target knee within 9 months prior to Screening, * Has concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active infection, etc.,) * Symptomatic OA of the contralateral knee or of either hip that is not responsive to paracetamol and requires other therapy, * Has related hypersensitivities to avian proteins and/or any components of hyaluronan-based injection devices,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale | Day 0, up to week 26 | The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | Week 26 | Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme. |
| Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale | Day 0, up to week 26 | The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty. |
| Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale | Day 0, Week 26 | The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty. |
| Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale | Day 0, Week 26 | The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain. |
| Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Week 26 | The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4. |
| Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26 | Week 26 | Participants were classified as a positive responder if at least one of the following two conditions were met: 1. A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR 2. Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU |
| Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Week 26 | The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4. |
Countries
Belgium, Czechia, France, Germany, Netherlands, United Kingdom
Participant flow
Pre-assignment details
329 participants enrolled and 76 screening failures. One participant was randomised to the Synvisc group but received Saline in error; counted in the Saline group for safety analyses (Safety population) and in the Synvisc group for efficacy analyses (Intent-to-treat population) in both study periods.
Participants by arm
| Arm | Count |
|---|---|
| Synvisc Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. | 124 |
| Saline Control Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline. | 129 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Initial Treatment Period | Adverse Event | 1 | 3 |
| Initial Treatment Period | Lack of Efficacy | 6 | 4 |
| Initial Treatment Period | Non-compliant | 1 | 2 |
| Initial Treatment Period | Other | 0 | 2 |
| Initial Treatment Period | Withdrawal by Subject | 1 | 1 |
| Repeat Treatment Period | Adverse Event | 1 | 0 |
| Repeat Treatment Period | Other | 1 | 0 |
Baseline characteristics
| Characteristic | Synvisc | Saline Control | Total |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 9.64 | 62.5 years STANDARD_DEVIATION 9.17 | 63.0 years STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black | 5 participants | 3 participants | 8 participants |
| Race/Ethnicity, Customized Caucasian | 118 participants | 125 participants | 243 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 92 Participants | 88 Participants | 180 Participants |
| Sex: Female, Male Male | 32 Participants | 41 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 70 / 123 | 77 / 130 | 9 / 77 | 11 / 83 |
| serious Total, serious adverse events | 5 / 123 | 3 / 130 | 0 / 77 | 2 / 83 |
Outcome results
Primary
Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.
Time frame: Day 0, up to week 26
Population: Intent-To-Treat (ITT) population which included all participants randomized to study treatment on Day 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc | Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale | -0.84 units on a scale | Standard Error 0.06 |
| Saline Control | Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale | -0.69 units on a scale | Standard Error 0.058 |
p-value: 0.047ANCOVA
Secondary
Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.
Time frame: Day 0, Week 26
Population: Intent-To-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc | Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale | -0.59 units on a scale | Standard Error 0.076 |
| Saline Control | Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale | -0.48 units on a scale | Standard Error 0.074 |
p-value: 0.266ANCOVA
Secondary
Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.
Time frame: Day 0, Week 26
Population: Intent-To-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc | Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale | -0.76 units on a scale | Standard Error 0.07 |
| Saline Control | Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale | -0.58 units on a scale | Standard Error 0.07 |
p-value: 0.064ANCOVA
Secondary
Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.
Time frame: Day 0, up to week 26
Population: Intent-To-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc | Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale | -0.66 units on a scale | Standard Error 0.061 |
| Saline Control | Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale | -0.63 units on a scale | Standard Error 0.059 |
p-value: 0.679ANCOVA
Secondary
Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26
The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.
Time frame: Week 26
Population: Intent-To-Treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synvisc | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Poor | 22 participants |
| Synvisc | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Very Well | 13 participants |
| Synvisc | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Well | 37 participants |
| Synvisc | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Fair | 38 participants |
| Synvisc | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Very Poor | 5 participants |
| Saline Control | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Very Poor | 6 participants |
| Saline Control | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Fair | 38 participants |
| Saline Control | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Very Well | 8 participants |
| Saline Control | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Poor | 34 participants |
| Saline Control | Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 | Well | 31 participants |
Comparison: Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using COGA data at Week 26.p-value: 0.02595% CI: [0.34, 0.93]Generalized Estimating Equations (GEE)
Secondary
Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26
The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.
Time frame: Week 26
Population: Intent-To-Treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synvisc | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Well | 33 participants |
| Synvisc | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Poor | 21 participants |
| Synvisc | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Fair | 50 participants |
| Synvisc | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Very Poor | 2 participants |
| Synvisc | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Very Well | 9 participants |
| Saline Control | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Very Poor | 3 participants |
| Saline Control | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Very Well | 2 participants |
| Saline Control | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Well | 27 participants |
| Saline Control | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Fair | 54 participants |
| Saline Control | Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 | Poor | 31 participants |
Comparison: Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using PTGA data at Week 26.p-value: 0.00595% CI: [0.31, 0.82]Generalized Estimating Equations (GEE)
Secondary
Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26
Participants were classified as a positive responder if at least one of the following two conditions were met: 1. A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR 2. Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU
Time frame: Week 26
Population: Intent-To-Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synvisc | Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26 | Responder - meets OMERACT-OARSI criteria | 73 participants |
| Synvisc | Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26 | NonResponder -does not meet OMERACT-OARSI criteria | 43 participants |
| Synvisc | Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26 | NonResponder - Withdrew Before Study Completion | 7 participants |
| Saline Control | Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26 | Responder - meets OMERACT-OARSI criteria | 66 participants |
| Saline Control | Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26 | NonResponder -does not meet OMERACT-OARSI criteria | 52 participants |
| Saline Control | Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26 | NonResponder - Withdrew Before Study Completion | 11 participants |
Comparison: Estimate of Odds Ratio (Placebo/Synvisc-One) using Responder classification data at Week 26.p-value: 0.15695% CI: [0.41, 1.16]Generalized Estimating Equations (GEE)
Secondary
Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale
Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme.
Time frame: Week 26
Population: Intent-To-Treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synvisc | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | Mild | 45 participants |
| Synvisc | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | Severe | 11 participants |
| Synvisc | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | Moderate | 41 participants |
| Synvisc | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | Extreme | 1 participants |
| Synvisc | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | None | 17 participants |
| Saline Control | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | Extreme | 4 participants |
| Saline Control | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | None | 13 participants |
| Saline Control | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | Mild | 39 participants |
| Saline Control | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | Moderate | 42 participants |
| Saline Control | Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale | Severe | 19 participants |
Comparison: Estimate of Odds Ratio (Placebo/Synvisc-One) using WOMAC A1 data at Week 26.p-value: 0.02295% CI: [0.35, 0.92]Generalized Estimating Equations (GEE)