Orthovisc
DeviceOrthovisc injection
Other names: Hyaluronic acid
NCT Number: NCT00436969
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
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Notify Me25 year–75 year
All sexes
Interventional
Phase 3
CORE Orthopedics, Encinitas, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Orthovisc injection
Other names: Hyaluronic acid
Celestone (betamethasone sodium phosphate and acetate) - 2 mL
Other names: Corticosteroid
Time frame: 6 Months
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.
Time frame: 6 Months
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 12 weeks
The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 6 months
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.
DePuy Mitek
Industry
A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial
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