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A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's). |
|
| Investigational | Experimental | Subjects randomized to the active treatment in this study will receive a one-time dose of 8 mL's of Orthovisc derived from non-animal source bacterial fermentation, S. Equi. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthovisc | Device | Orthovisc injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score (Per Protocol) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. | 6 Months |
| Visual Analog Scale (VAS) Pain Score (As Treated) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months. | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan B. McGlohorn | DePuy Synthes Mitek and Biomaterials | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CORE Orthopedics | Encinitas | California | 92024 | United States | ||
| Sierra Pacific Orthopaedic Center Medical Group |
We will not submit the data to FDA, and as such will not be making IPD available.
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Four subjects were randomized; however due to required imaging inclusion/exclusion criteria was not met. Hence, these 4 subjects were not treated.
Enrollment occurred between January 2007 and February 2010 at 13 sites based in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone). |
| FG001 | Investigational | Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The number of partipants analyzed were all 270 subjects that received treatment (87 control, 183 investigational).
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone). |
| BG001 | Investigational | Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Visual Analog Scale (VAS) Pain Score (Per Protocol) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. | Posted | Least Squares Mean | Standard Error | mm on a 100 mm VAS scale | 6 Months |
|
The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months
All subjects that received study treatment are included in the safety population.
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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 | Control | Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain - Cardiac Cath to Rule Out Cad | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment | Angina pectoris |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aileen Michael | DePuy Mitek | 508.828.3337 | amichae2@its.jnj.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Control | Drug | Celestone (betamethasone sodium phosphate and acetate) - 2 mL |
|
|
| Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months. | Baseline and 6 months |
| Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale. | Baseline and 12 weeks |
| Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. The difference in pain was calculated as visit score - baseline score. | Baseline and 12 weeks |
| American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function. | Baseline and 12 weeks |
| American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated) | The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function. | Baseline and 12 weeks |
| American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol) | The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function. | Baseline and 6 months |
| American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated) | The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function. | Baseline and 6 months |
| Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score. | Baseline and 12 weeks |
| Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated) | The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score. | Baseline and 12 weeks |
| Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol) | The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score. | Baseline and 6 months |
| Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated) | The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score. | Baseline and 6 months |
| 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline and 12 weeks |
| 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated) | The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline and 12 weeks |
| 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol) | The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline and 6 months |
| 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated) | The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline and 6 months |
| 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline and 12 weeks |
| 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated) | The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline and 12 weeks |
| 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol) | The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline and 6 months |
| 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated) | The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline and 6 months |
| Fresno |
| California |
| 93720 |
| United States |
| UHZ Sports Medicine | Coral Gables | Florida | 33146 | United States |
| Andrews Research Institute | Gulf Breeze | Florida | 32561 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| University of Massachusetts Merdical School - Worcester | Worcester | Massachusetts | 01605 | United States |
| Shores Rheumatology | Saint Clair Shores | Michigan | 48081 | United States |
| Insall Scott Kelly Institute | New York | New York | 10065 | United States |
| Tulsa Bone and Joint | Tulsa | Oklahoma | 74146 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| The Methodist | Houston | Texas | 11030 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
|
|
|
| Secondary | Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and 6 months |
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| Secondary | Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and 6 months |
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| Secondary | Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks). | Posted | Least Squares Mean | Standard Error | mm on a 100 mm VAS scale | Baseline and 12 weeks |
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| Secondary | Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. The difference in pain was calculated as visit score - baseline score. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | mm on a 100 mm VAS scale | Baseline and 12 weeks |
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| Secondary | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
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| Secondary | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated) | The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
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| Secondary | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol) | The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 6 months |
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| Secondary | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated) | The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 6 months |
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| Secondary | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
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| Secondary | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated) | The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
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| Primary | Visual Analog Scale (VAS) Pain Score (As Treated) | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | mm on a 100 mm VAS scale | 6 Months |
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| Secondary | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol) | The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 6 months |
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| Secondary | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated) | The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 6 months |
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| Secondary | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
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| Secondary | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated) | The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
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| Secondary | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol) | The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 6 months |
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| Secondary | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated) | The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 6 months |
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| Secondary | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol) | The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
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| Secondary | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated) | The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
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| Secondary | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol) | The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 6 months |
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| Secondary | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated) | The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | The As Treated analysis population included all subjects that received treatment and had outcome data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 6 months |
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| 3 |
| 87 |
| 6 |
| 87 |
| EG001 | Investigational | Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder. | 10 | 183 | 19 | 183 |
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| Knee Pain Both Knees | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment | Arthralgia |
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| Shoulder Pain (Index Shoulder) Right Shoulder | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment | Musculoskeletal pain |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment | Breast Cancer Female |
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| Patient has cancer, did not specify to PI where cancer is, never returned, lost to follow-up | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment | Neoplasm malignant |
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| Total Shoulder Arthroplasty Plus Bone Graft Glenoid Scapular Right Shoulder | Surgical and medical procedures | MedDRA (14.0) | Non-systematic Assessment | Shoulder Arthroplasty |
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| Left Shoulder Pain Non-Study Shoulder - Surgery 6/10/09 | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment | Musculoskeletal pain |
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| Quadruple Bypass 5/6/09 | Surgical and medical procedures | MedDRA (14.0) | Non-systematic Assessment | Coronary artery bypass |
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| Iliopsoas Abscess | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment | Abscess |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment | Back pain |
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| Open Heart Surgery After Aortic Valve Disease | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment | Aortic valve disease |
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Not provided
| Superiority or Other |