Glenohumeral Osteoarthritis Clinical Trial
Official title:
A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial
Verified date | November 2016 |
Source | DePuy Mitek |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
Status | Completed |
Enrollment | 274 |
Est. completion date | August 2011 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
United States | UHZ Sports Medicine | Coral Gables | Florida |
United States | CORE Orthopedics | Encinitas | California |
United States | Sierra Pacific Orthopaedic Center Medical Group | Fresno | California |
United States | Andrews Research Institute | Gulf Breeze | Florida |
United States | The Methodist | Houston | Texas |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Insall Scott Kelly Institute | New York | New York |
United States | Shores Rheumatology | St Clair Shores | Michigan |
United States | University Orthopedics Center | State College | Pennsylvania |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | Tulsa Bone and Joint | Tulsa | Oklahoma |
United States | University of Massachusetts Merdical School - Worcester | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
DePuy Mitek |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 6 Months | |
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. | 6 Months | |
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. |
Baseline and 6 months | |
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. |
Baseline and 6 months | |
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. | Baseline and 12 weeks | |
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. |
Baseline and 12 weeks | |
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. |
Baseline and 12 weeks | |
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. |
Baseline and 12 weeks | |
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. |
Baseline and 6 months | |
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. |
Baseline and 6 months | |
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. |
Baseline and 12 weeks | |
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. |
Baseline and 12 weeks | |
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. |
Baseline and 6 months | |
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. |
Baseline and 6 months | |
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. |
Baseline and 12 weeks | |
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. |
Baseline and 12 weeks | |
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. |
Baseline and 6 months | |
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. |
Baseline and 6 months | |
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. |
Baseline and 12 weeks | |
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. |
Baseline and 12 weeks | |
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. |
Baseline and 6 months | |
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. |
Baseline and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01726972 -
A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
|
||
Completed |
NCT06043544 -
Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis:
|
Phase 4 | |
Recruiting |
NCT05847062 -
Clinical Trial to Analyze Lateralized Models and Medializations of Inverted Arthroplasty.
|
N/A | |
Recruiting |
NCT04105478 -
Comparison of Stemless and Stemmed Shoulder Arthroplasty for Osteoarthritis
|
N/A | |
Recruiting |
NCT03866330 -
Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis
|
Phase 1/Phase 2 | |
Recruiting |
NCT04845074 -
Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis
|
N/A | |
Terminated |
NCT03586687 -
Osteoarthritis Shoulder Injection Study
|
Phase 4 | |
Completed |
NCT03379545 -
3D MR Versus 3D CT for Glenohumeral Arthritis
|
N/A | |
Recruiting |
NCT06269705 -
ZILRETTA in Subjects With Glenohumeral Osteoarthritis
|
Phase 3 | |
Active, not recruiting |
NCT06171542 -
Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis
|
Phase 1 | |
Recruiting |
NCT03869229 -
Adipose-derived Mesenchymal Stem Cells in Osteoarthritis
|
Phase 1/Phase 2 | |
Completed |
NCT00500630 -
Objective Evaluation of Shoulder Pathology and Surgery
|
N/A |