Reverse Shoulder Prosthesis Study

Phase 3

Completed

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

Interventions: Device: Reverse Shoulder Prosthesis

Registration Number: NCT00764504

Lead Sponsor: Encore Medical, L.P.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 516

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary	Reverse Shoulder Prosthesis	Primary shoulder
Revision	Reverse Shoulder Prosthesis	Revision shoulder
Continued Access	Reverse Shoulder Prosthesis	Primary shoulder subjects enrolled at a later date in order to collect more data.

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons Shoulder Score	2-year	The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation: \[(10 - Visual analog scale pain score) x 5\] + \[(5/3) x Cumulative ADL score\]
Average Range of Motion	2-year	Physician's assessment of a subject's range of motion in degrees.
Subject Satisfaction With Surgery	2-year	Each subject had a chance to rate their satisfaction with surgery at each study interval.
Have Surgery Again?	2-year	Subject satisfaction: subject's willingness to have surgery performed again if necessary.
Neer's "Limited Goals"	2-year	To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit \>90 degrees active forward elevation and exhibit \>20 degrees of active external rotation.
Radiographic Failures	Post-operative, 3-month, 6-month, 1-year, 2-year	Radiographic failure is defined as a shift in the position of the component \>3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a \>2mm radiolucency completely around either prosthesis.
Safety Assessment	2-year	Number of device related adverse events and device failures at the 2 year time frame.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (23): University of Colorado
🇺🇸
Denver, Colorado, United States
Hospital for Special Surgery
🇺🇸
New York, New York, United States
Arthritis Orthopedics and Sports Medicine
🇺🇸
Glendale, California, United States
Advanced Orthopedic and Sports Medicine Specialists, P.C.
🇺🇸
Lonetree, Colorado, United States
The Carrell Clinic
🇺🇸
Dallas, Texas, United States
Orthopedic Specialists
🇺🇸
Towson, Maryland, United States
Atlantis Orthopaedics
🇺🇸
Atlantis, Florida, United States
Orthopaedic Surgery & Sports Medicine
🇺🇸
Jupiter, Florida, United States
UNC School of Medicine
🇺🇸
Chapel Hill, North Carolina, United States
Florida Orthopedic Institute
🇺🇸
Temple Terrace, Florida, United States
TRIA Orthopaedic Center
🇺🇸
Bloomington, Minnesota, United States
Cincinnati Sports Medicine & Orthopaedic Center
🇺🇸
Crestview, Kentucky, 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
Orthopedic Associates of Dallas
🇺🇸
Dallas, Texas, United States
Unlimited Research
🇺🇸
San Antonio, Texas, United States
Steadman Hawkins SPT Medical Foundation
🇺🇸
Vail, Colorado, United States
Palm Beach Orthopaedic Institute
🇺🇸
Palm Beach Gardens, Florida, United States
Orthopaedic Specialty Institute
🇺🇸
Orange, California, United States
Orthopedic Center of the Rockies
🇺🇸
Ft. Collins, Colorado, United States
Orthopedic Institute
🇺🇸
Tyler, Texas, United States
Orthopedic Specialty Associates, P.A.
🇺🇸
Ft. Worth, Texas, United States