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ORTHOVISC Shoulder RCT (OV Shoulder)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Mitek
ClinicalTrials.gov Identifier:
NCT00436969
First received: February 16, 2007
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Glenohumeral Osteoarthritis
Device: Orthovisc
Drug: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by DePuy Mitek:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) Pain Score (Per Protocol) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 275
Study Start Date: December 2006
Study Completion Date: August 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's).
Drug: Control
Celestone (betamethasone sodium phosphate and acetate) - 2 mL
Drug: Control
Marcaine (bupivacaine) - 6 mL
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.
Device: Orthovisc
Orthovisc injection

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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436969

Locations
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
Sponsors and Collaborators
DePuy Mitek
Investigators
Study Director: Jonathan B. McGlohorn DePuy Synthes Mitek and Biomaterials
  More Information

No publications provided

Responsible Party: DePuy Mitek
ClinicalTrials.gov Identifier: NCT00436969     History of Changes
Other Study ID Numbers: 06-OV-01
Study First Received: February 16, 2007
Results First Received: August 13, 2013
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Mitek:
Orthovisc
Osteoarthritis
Shoulder
Randomized

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Viscosupplements

ClinicalTrials.gov processed this record on November 25, 2014