Glenohumeral OsteoarthritisPhase 3NCT00436969
ORTHOVISC Shoulder Osteoarthritis Study
A Phase 3 study testing Orthovisc in people with Glenohumeral Osteoarthritis, run by DePuy Mitek at 13 sites in United States.
Trial summary
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Glenohumeral Osteoarthritis
- What is being tested?
- Orthovisc
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2006to Aug 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A candidate for unilateral treatment of osteoarthritis of the shoulder
- Have failed conservative treatment
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Virginia
Charlottesville, Virginia, 22908
UHZ Sports Medicine
Coral Gables, Florida, 33146
CORE Orthopedics
Encinitas, California, 92024
Sierra Pacific Orthopaedic Center Medical Group
Fresno, California, 93720
Andrews Research Institute
Gulf Breeze, Florida, 32561
The Methodist
Houston, Texas, 11030
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Insall Scott Kelly Institute
New York, New York, 10065
Shores Rheumatology
Saint Clair Shores, Michigan, 48081
University Orthopedics Center
State College, Pennsylvania, 16801
Madigan Army Medical Center
Tacoma, Washington, 98431
Tulsa Bone and Joint
Tulsa, Oklahoma, 74146
University of Massachusetts Merdical School - Worcester
Worcester, Massachusetts, 01605
About this study
Official title: A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
Read the 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.
- Conditions
- Glenohumeral Osteoarthritis
- Being tested
- Orthovisc, Control
- Keywords
- Orthovisc, Osteoarthritis, Shoulder, Randomized
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoviscDevice
Also called Hyaluronic acid
Orthovisc injection
ControlDrug
Also called Corticosteroid
Celestone (betamethasone sodium phosphate and acetate) - 2 mL
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's). Receives: Drug: Control |
| Investigational | Experimental | 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. Receives: Device: Orthovisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
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.
Measured: 6 Months
Secondary outcomes (20)
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionFeb 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glenohumeral OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Mitek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan B. McGlohorn, Study director, DePuy Synthes Mitek and Biomaterials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436969
- Sponsor's protocol ID
- 06-OV-01
- Status last verified
- Nov 2016
- First submitted
- 16 Feb 2007
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: We will not submit the data to FDA, and as such will not be making IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00436969
- Acronym / sponsor ID
- 06-OV-01
- Conditions
- Glenohumeral Osteoarthritis
- Keywords
- Orthovisc, Osteoarthritis, Shoulder, Randomized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- DePuy MitekIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Posted 11 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: ControlSubjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's). |
| Investigational | Experimental | Device: OrthoviscSubjects 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A candidate for unilateral treatment of osteoarthritis of the shoulder
- Have failed conservative treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrthoviscAlso: Hyaluronic acidOrthovisc injection | Device | Investigational |
| ControlAlso: CorticosteroidCelestone (betamethasone sodium phosphate and acetate) - 2 mL | Drug | Control |
Primary outcome
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.
20 secondary outcomes
Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)
Time frame: Baseline and 6 months
Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)
Time frame: Baseline and 6 months
Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)
Time frame: Baseline and 12 weeks
Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)
Time frame: Baseline and 12 weeks
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)
Time frame: Baseline and 12 weeks
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)
Time frame: Baseline and 12 weeks
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)
Time frame: Baseline and 6 months
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)
Time frame: Baseline and 6 months
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)
Time frame: Baseline and 12 weeks
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)
Time frame: Baseline and 12 weeks
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)
Time frame: Baseline and 6 months
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)
Time frame: Baseline and 6 months
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)
Time frame: Baseline and 12 weeks
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)
Time frame: Baseline and 12 weeks
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)
Time frame: Baseline and 6 months
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)
Time frame: Baseline and 6 months
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)
Time frame: Baseline and 12 weeks
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)
Time frame: Baseline and 12 weeks
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)
Time frame: Baseline and 6 months
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We will not submit the data to FDA, and as such will not be making IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan B. McGlohorn study director
DePuy Synthes Mitek and Biomaterials
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orthovisc in people with Glenohumeral Osteoarthritis, run by DePuy Mitek at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain Score (Per Protocol) (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.