- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01005446
Reverse Shoulder Prosthesis Prospective Multi-Center Study
March 26, 2021 updated by: Encore Medical, L.P.
PS-901: Prospective Multicenter Open Label Study of the Encore Reverse® Shoulder Prosthesis
The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term.
A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency.
The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department.
The study will include only subjects who meet the indications for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.
Study Type
Observational
Enrollment (Actual)
245
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Redwood City, California, United States, 94063
- Stanford University - Dept. of Orthopedics
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Florida
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Bradenton, Florida, United States, 34209
- Coastal Orthopedics & Sports Medicine
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Fort Lauderdale, Florida, United States, 33334
- Orthopaedic Institute at Holy Cross Hospital
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Illinois
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Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40241
- Norton Orthopaedic & Sports Medicine Specialists
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New York
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Amherst, New York, United States, 14226
- Excelsior Orthopaedics
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Ohio
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Cincinnati, Ohio, United States, 45242
- Cincinnati Sports Medicine and Orthopeadic Center
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Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Texas
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Plano, Texas, United States, 75093
- Texas Center for Joint Replacement
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Utah
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Saint George, Utah, United States, 84790
- Rimrock Orthopedics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects who are 60 years of age or older at the time of consent and are suffering from a grossly rotator cuff deficient shoulder joints with severe arthropathy or have a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
Description
Inclusion Criteria:
- Subject must be a candidate for a total shoulder joint replacement
- Subject must be diagnosed with one or more of the following conditions:
Irreparable rotator cuff tear with gleno-humeral arthritis; Failed rotator cuff surgery with gleno-humeral instability or antero- superior escape; Failed shoulder replacement surgery
- Subject has a functional deltoid muscle
- Subject's joint must be anatomically and functionally suited to receive the selected implant
- Subject is 60 years of age or older (≥ 60 yrs of age) at time of consent
- Subject is likely to be available for all study visits
- Subject is able and willing to sign the informed consent and follow study procedures
- Subject is not pregnant
Exclusion Criteria:
- Subject has a non-functional deltoid muscle
- Subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is a prisoner
- Subject has high levels of physical activity (ex. competitive sports, heavy physical labor)
- Subject is pregnant
- Subject has an active infection or sepsis
- Subject has loss of ligamentous structures
- Subject has a history of alcoholism or other addictions (current or past)
- Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Syringomyelia and Multiple Sclerosis, Charcot joints)
- Subject has severe glenoid bone loss
- Subject has known materials sensitivity (to metals)
- Subject is younger than 60 years of age (< 60 years of age) at consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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RSP Device
Post Market Study
|
The RSP is indicated for use in subjects with grossly rotator cuff deficient shoulder joints with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline
Time Frame: 2 year
|
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline.
Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiologic Success
Time Frame: 5 year
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Changes in radiolucency compared with Baseline
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5 year
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Change in ASES score from Baseline
Time Frame: 5 year
|
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline.
Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.
|
5 year
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SF36- (Short Form 36)Health Survey
Time Frame: 5 year
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Change from baseline using the SF36-Health Status.
There are multiple scales for general health, pain and activities of daily living
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5 year
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Change in Simple Shoulder Test from Baseline
Time Frame: 5 year
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Change in Simple Shoulder Test from Baseline.
Twelve questions about pain and functionality with responses being yes or no
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5 year
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Subject Satisfaction Survey
Time Frame: 5 year
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Patient Related Outcome of Device Satisfaction (score 1-5 with 1 = best and 5 = worst) Device satisfaction
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5 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Samer S. Hasan, M.D., Cincinnati Sports Medicine and Orthopaedic Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
October 30, 2009
First Submitted That Met QC Criteria
October 30, 2009
First Posted (Estimate)
November 1, 2009
Study Record Updates
Last Update Posted (Actual)
March 30, 2021
Last Update Submitted That Met QC Criteria
March 26, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PS - 901
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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