Reverse Shoulder Prosthesis Prospective Multi-Center Study
PS-901: Prospective Multicenter Open Label Study of the Encore Reverse® Shoulder Prosthesis
1 other identifier
observational
245
1 country
10
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2009
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2009
CompletedFirst Posted
Study publicly available on registry
November 2, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMarch 30, 2021
March 1, 2021
7.7 years
October 30, 2009
March 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline
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 Outcomes (5)
Radiologic Success
5 year
Change in ASES score from Baseline
5 year
SF36- (Short Form 36)Health Survey
5 year
Change in Simple Shoulder Test from Baseline
5 year
Subject Satisfaction Survey
5 year
Study Arms (1)
RSP Device
Post Market Study
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Encore Medical, L.P.lead
- DJO Incorporatedcollaborator
Study Sites (10)
Stanford University - Dept. of Orthopedics
Redwood City, California, 94063, United States
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, 34209, United States
Orthopaedic Institute at Holy Cross Hospital
Fort Lauderdale, Florida, 33334, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612, United States
Norton Orthopaedic & Sports Medicine Specialists
Louisville, Kentucky, 40241, United States
Excelsior Orthopaedics
Amherst, New York, 14226, United States
Cincinnati Sports Medicine and Orthopeadic Center
Cincinnati, Ohio, 45242, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Texas Center for Joint Replacement
Plano, Texas, 75093, United States
Rimrock Orthopedics
St. George, Utah, 84790, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Samer S. Hasan, M.D.
Cincinnati Sports Medicine and Orthopaedic Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2009
First Posted
November 2, 2009
Study Start
December 1, 2009
Primary Completion
August 1, 2017
Study Completion
June 1, 2018
Last Updated
March 30, 2021
Record last verified: 2021-03