ORTHOVISC Shoulder Osteoarthritis Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00436969 |
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Recruitment Status :
Completed
First Posted : February 19, 2007
Results First Posted : April 11, 2014
Last Update Posted : March 9, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glenohumeral Osteoarthritis | Device: Orthovisc Drug: Control | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 274 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial |
| Study Start Date : | December 2006 |
| Actual Primary Completion Date : | February 2010 |
| Actual Study Completion Date : | August 2011 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Control
Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's).
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Drug: Control
Celestone (betamethasone sodium phosphate and acetate) - 2 mL
Other Name: Corticosteroid |
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Experimental: Investigational
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.
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Device: Orthovisc
Orthovisc injection
Other Name: Hyaluronic acid |
- Visual Analog Scale (VAS) Pain Score (Per Protocol) [ 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.
- Visual Analog Scale (VAS) Pain Score (As Treated) [ 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.
- Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol) [ 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.
- Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated) [ 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.
- Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol) [ 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.
- Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated) [ 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.
- American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol) [ 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.
- American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated) [ 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.
- American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol) [ 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.
- American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated) [ 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.
- Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol) [ 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.
- Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated) [ 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.
- Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol) [ 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.
- Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated) [ 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.
- 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol) [ 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.
- 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated) [ 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.
- 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol) [ 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.
- 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated) [ 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.
- 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol) [ 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.
- 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated) [ 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.
- 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol) [ 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.
- 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated) [ 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 25 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436969
| United States, California | |
| CORE Orthopedics | |
| Encinitas, California, United States, 92024 | |
| Sierra Pacific Orthopaedic Center Medical Group | |
| Fresno, California, United States, 93720 | |
| United States, Florida | |
| UHZ Sports Medicine | |
| Coral Gables, Florida, United States, 33146 | |
| Andrews Research Institute | |
| Gulf Breeze, Florida, United States, 32561 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Massachusetts | |
| University of Massachusetts Merdical School - Worcester | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Michigan | |
| Shores Rheumatology | |
| St Clair Shores, Michigan, United States, 48081 | |
| United States, New York | |
| Insall Scott Kelly Institute | |
| New York, New York, United States, 10065 | |
| United States, Oklahoma | |
| Tulsa Bone and Joint | |
| Tulsa, Oklahoma, United States, 74146 | |
| United States, Pennsylvania | |
| University Orthopedics Center | |
| State College, Pennsylvania, United States, 16801 | |
| United States, Texas | |
| The Methodist | |
| Houston, Texas, United States, 11030 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431 | |
| Study Director: | Jonathan B. McGlohorn | DePuy Synthes Mitek and Biomaterials |
| Responsible Party: | DePuy Mitek |
| ClinicalTrials.gov Identifier: | NCT00436969 |
| Other Study ID Numbers: |
06-OV-01 |
| First Posted: | February 19, 2007 Key Record Dates |
| Results First Posted: | April 11, 2014 |
| Last Update Posted: | March 9, 2017 |
| Last Verified: | November 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | We will not submit the data to FDA, and as such will not be making IPD available. |
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Orthovisc Osteoarthritis Shoulder Randomized |
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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Hyaluronic Acid |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |