ORTHOVISC Shoulder Osteoarthritis Study

Glenohumeral Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436969
• Other study ID #: 06-OV-01
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2007
• Last updated: January 27, 2017
• Start date: December 2006
• Est. completion date: August 2011

Study information

• Verified date: November 2016
• Source: DePuy Mitek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Glenohumeral Osteoarthritis
• Osteoarthritis

Intervention

Device:
• Orthovisc
Orthovisc injection

Drug:
• Control
Celestone (betamethasone sodium phosphate and acetate) - 2 mL

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Mitek

Country where clinical trial is conducted

United States, 

Outcome

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