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| Name | Class |
|---|---|
| United States Naval Medical Center, Portsmouth | FED |
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The purpose of this study is to evaluate whether the investigators can develop a computer algorithm to predict which individual patients will respond to injections of hyaluronic acid (HA) products for knee osteoarthritis.
Background Osteoarthritis (OA) of the knee is a debilitating condition that affects an estimated 21 million Americans. This number is expected to rise steadily as the population ages. The medical expenditures associated with arthritis and other rheumatic conditions in the United States have increased from $50 billion in 1997 to $86 billion in 2003. In 2003, almost 420,000 total knee replacements were performed, primarily for arthritis. Injections of hyaluronic acid (HA) have been shown to provide symptom relief for many OA patients who have failed to respond to conservative interventions. Many other patients, however, experience only slight or no improvement. The results from this study will allow physicians to identify whether a patient is likely or not likely to respond well to HA therapy leading to improved treatment success rates.
Goals This study has two related goals: 1) to identify patient and treatment factors that predict response to intra-articular injections of hyaluronic acid for knee osteoarthritis using multivariable analysis and 2) develop mathematical and statistical models that will predict individual patient response to HA for knee OA.
It is anticipated that the investigators will develop computer software in this study that can support clinical decision making related to viscosupplementation in the treatment of knee OA. If this project yields successful patient predictive models, physicians who are considering a trial of HA for a patient will have some empirical basis for treatment selection. Eventually a physician would be able to assess a relatively small number of variables for a patient and then be provided with predictions regarding treatment response.
**Please note that the study site at the Naval Medical Center in Portsmouth, Virginia can only enroll patients who are eligible to be treated at a military facility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synvisc (hylan G-F 20) | Active Comparator |
| |
| Euflexxa (1% sodium hyaluronate) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hylan G-F 20 | Device | Three 2 cc injections at weekly intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale | The KOOS is 42-item patient-report questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It yields scores for five scales including Pain, Other Symptoms, Function in Daily Living, Function in Sport/Recreation, and Knee-Related Quality of Life. We used only the Pain scale which has a range of 0 to 100 where 100 represents the "best" score, i.e., no pain. We reported differences in baseline Pain scale score from Pain scale score at 6 months so these scores could theoretically range from -100 (moving from no pain to maximum pain) to 100 (moving from maximum pain to no pain). Positive change scores represent improvement from baseline. | Baseline and at 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) at 6 Months | The VAS is a patient-reported assessment of knee pain. Patients mark on a line (0-100mm) their current level of knee pain while moving where 0 represent no pain and 100 represents maximum pain. We report changes in VAS pain rating between baseline and 6 month follow-up. Therefore scores can theoretically range from -100 (moving from maximum pain to no pain) to 100 (moving from no pain to maximum pain). Negative change scores represent decreases in perceived pain or improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Marx, MD | Hospital for Special Surgery, New York | Study Chair |
| Marlene DeMaio, MD | United States Naval Medical Center, Portsmouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center Portsmouth (this site can only enroll patients who are eligible to be treated at a military facility) | Portsmouth | Virginia | 23708-2197 | United States |
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| Label | URL |
|---|---|
| Information on Osteoarthritis from the National Institutes of Health | View source |
| Cochrane Review Article Abstract on Viscosupplementation for Knee Osteoarthritis | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Synvisc (Hylan G-F 20) | hylan G-F 20: Three 2 cc injections at weekly intervals |
| FG001 | Euflexxa (1% Sodium Hyaluronate) | 1% sodium hyaluronate: Three 2 cc injections at weekly intervals |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Synvisc (Hylan G-F 20) | hylan G-F 20: Three 2 cc injections at weekly intervals |
| BG001 | Euflexxa (1% Sodium Hyaluronate) | 1% sodium hyaluronate: Three 2 cc injections at weekly intervals |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale | The KOOS is 42-item patient-report questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It yields scores for five scales including Pain, Other Symptoms, Function in Daily Living, Function in Sport/Recreation, and Knee-Related Quality of Life. We used only the Pain scale which has a range of 0 to 100 where 100 represents the "best" score, i.e., no pain. We reported differences in baseline Pain scale score from Pain scale score at 6 months so these scores could theoretically range from -100 (moving from no pain to maximum pain) to 100 (moving from maximum pain to no pain). Positive change scores represent improvement from baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and at 6 month follow-up |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Synvisc (Hylan G-F 20) | hylan G-F 20: Three 2 cc injections at weekly intervals |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee Effusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barton Mann | American Orthopaedic Society for Sports Medicine | 847-292-4900 | bart@aossm.org |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 1% sodium hyaluronate | Device | Three 2 cc injections at weekly intervals |
|
|
| Assessments were at baseline to 6 month follow-up |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Euflexxa (1% Sodium Hyaluronate) | 1% sodium hyaluronate: Three 2 cc injections at weekly intervals |
|
|
| Secondary | Visual Analogue Scale (VAS) at 6 Months | The VAS is a patient-reported assessment of knee pain. Patients mark on a line (0-100mm) their current level of knee pain while moving where 0 represent no pain and 100 represents maximum pain. We report changes in VAS pain rating between baseline and 6 month follow-up. Therefore scores can theoretically range from -100 (moving from maximum pain to no pain) to 100 (moving from no pain to maximum pain). Negative change scores represent decreases in perceived pain or improvement. | The discrepancy between the number of subjects included in this analysis (140) and the number of subjects reported completing the study (141) is due to a missing values for one subject for this variable. | Posted | Mean | Standard Deviation | units on a scale | Assessments were at baseline to 6 month follow-up |
|
|
|
| 8 |
| 103 |
| 0 |
| 103 |
| EG001 | Euflexxa (1% Sodium Hyaluronate) | 1% sodium hyaluronate: Three 2 cc injections at weekly intervals | 1 | 95 | 0 | 95 |
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| D012216 |
| Rheumatic Diseases |