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Completed

NCT Number: NCT00436969

ORTHOVISC Shoulder Osteoarthritis Study

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

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CORE Orthopedics, Encinitas, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthovisc

Device

Orthovisc injection

Other names: Hyaluronic acid

Control

Drug

Celestone (betamethasone sodium phosphate and acetate) - 2 mL

Other names: Corticosteroid

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

Sponsors and collaborators

Lead sponsor

DePuy Mitek

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Feb 19, 2007
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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