Reverse Shoulder Prosthesis Prospective Multi-Center Study

Completed

Conditions studied: Rotator Cuff Deficiency, Shoulder Arthropathy, Failed Shoulder Replacement

In brief

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).

Key facts

Study ID

NCT01005446

Run by

Encore Medical, L.P.

People needed

245

Starts

2009-12-01

Expected to finish

2018-06-01

Last updated by the study team

2021-03-30

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Stanford University - Dept. of Orthopedics — Redwood City, California, United States
• Coastal Orthopedics & Sports Medicine — Bradenton, Florida, United States
• Orthopaedic Institute at Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Rush-Presbyterian-St. Luke's Medical Center — Chicago, Illinois, United States
• Norton Orthopaedic & Sports Medicine Specialists — Louisville, Kentucky, United States
• Excelsior Orthopaedics — Amherst, New York, United States
• Cincinnati Sports Medicine and Orthopeadic Center — Cincinnati, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Texas Center for Joint Replacement — Plano, Texas, United States
• Rimrock Orthopedics — St. George, Utah, United States

Full record on ClinicalTrials.gov

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