ORTHOVISC Shoulder Osteoarthritis Study
- Conditions
- Glenohumeral Osteoarthritis
- Interventions
- Drug: ControlDevice: Orthovisc
- Registration Number
- NCT00436969
- Lead Sponsor
- DePuy Mitek
- Brief Summary
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
- A candidate for unilateral treatment of osteoarthritis of the shoulder
- Have failed conservative treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's). Investigational Orthovisc 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.
- Primary Outcome Measures
Name Time Method Visual Analog Scale (VAS) Pain Score (Per Protocol) 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.
Visual Analog Scale (VAS) Pain Score (As Treated) 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.
- Secondary Outcome Measures
Name Time Method American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol) 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.American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated) 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.Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol) 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.Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated) 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.Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol) 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.
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol) 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.12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated) 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.Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated) 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.Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol) 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.Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol) 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.12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated) 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.12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol) 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.American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol) 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.Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated) 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.12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol) 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.American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated) 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.Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated) 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.12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol) 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.12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated) 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.12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated) 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.
Trial Locations
- Locations (13)
CORE Orthopedics
🇺🇸Encinitas, California, United States
Sierra Pacific Orthopaedic Center Medical Group
🇺🇸Fresno, California, United States
UHZ Sports Medicine
🇺🇸Coral Gables, Florida, United States
Andrews Research Institute
🇺🇸Gulf Breeze, Florida, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of Massachusetts Merdical School - Worcester
🇺🇸Worcester, Massachusetts, United States
Shores Rheumatology
🇺🇸St Clair Shores, Michigan, United States
Insall Scott Kelly Institute
🇺🇸New York, New York, United States
Tulsa Bone and Joint
🇺🇸Tulsa, Oklahoma, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States
Scroll for more (3 remaining)CORE Orthopedics🇺🇸Encinitas, California, United States