ORTHOVISC Shoulder Osteoarthritis Study

Study Overview
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Brief Summary
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A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.

Detailed Description
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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.

Official Title
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A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial

Conditions
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Glenohumeral Osteoarthritis

Intervention / Treatment
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* Device: Orthovisc
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A candidate for unilateral treatment of osteoarthritis of the shoulder Have failed conservative treatment Exclusion Criteria: Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function No active instability or acute dislocation episodes within the previous 12 months Known allergy to hyaluronate preparations Pregnant or breast feeding Is receiving prescription pain medication for conditions unrelated to the index shoulder condition

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's). | Drug: Control<br>* Celestone (betamethasone sodium phosphate and acetate) - 2 mL<br>* Other names: Corticosteroid;|
| Experimental: Investigational<br>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. | Device: Orthovisc<br>* Orthovisc injection<br>* Other names: Hyaluronic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthovisc, Osteoarthritis, Shoulder, Randomized