Reverse Shoulder Prosthesis Study

Completed · Phase 3

Conditions studied: Rotator Cuff Arthropathy, Failed Total Shoulder, Failed Hemi-arthroplasty

In brief

The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.

Key facts

Study ID

NCT00764504

Run by

Encore Medical, L.P.

People needed

516

Starts

2002-10-01

Expected to finish

2008-08-01

Last updated by the study team

2011-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff
• Evidence of upward displacement of the humeral head with respect to the glenoid
• Loss of glenohumeral joint space
• Functional deltoid muscle
• Patient is likely to be available for evaluation for the duration of the study
• Visual Analog Pain Scale 5 or greater

You may not qualify if…

• Non functional deltoid muscle
• Active sepsis
• Excessive glenoid bone loss
• Pregnancy
• Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.
• Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease.
• Prisoners
• Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
• Known metal allergy (i.e., jewelry).
• Visual Analog Pain Scale <5.

Where it is running

• Arthritis Orthopedics and Sports Medicine — Glendale, California, United States
• Orthopaedic Specialty Institute — Orange, California, United States
• University of Colorado — Denver, Colorado, United States
• Orthopedic Center of the Rockies — Fort Collins, Colorado, United States
• Advanced Orthopedic and Sports Medicine Specialists, P.C. — Lonetree, Colorado, United States
• Steadman Hawkins SPT Medical Foundation — Vail, Colorado, United States
• Atlantis Orthopaedics — Atlantis, Florida, United States
• Orthopaedic Surgery & Sports Medicine — Jupiter, Florida, United States
• Palm Beach Orthopaedic Institute — Palm Beach Gardens, Florida, United States
• Florida Orthopedic Institute — Temple Terrace, Florida, United States
• Study site — Atlanta, Georgia, United States
• Cincinnati Sports Medicine & Orthopaedic Center — Crestview, Kentucky, United States
• Study site — Lutherville, Maryland, United States
• Orthopedic Specialists — Towson, Maryland, United States
• TRIA Orthopaedic Center — Bloomington, Minnesota, United States
• Hospital for Special Surgery — New York, New York, United States
• UNC School of Medicine — Chapel Hill, North Carolina, United States
• Crystal Clinic — Akron, Ohio, United States
• Bone & Joint Hospital, LLC — Oklahoma City, Oklahoma, United States
• Orthopedic Research Foundation of the Carolinas — Spartanburg, South Carolina, United States
• The Carrell Clinic — Dallas, Texas, United States
• Orthopedic Associates of Dallas — Dallas, Texas, United States
• Orthopedic Specialty Associates, P.A. — Fort Worth, Texas, United States
• Unlimited Research — San Antonio, Texas, United States
• Orthopedic Institute — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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