Clinical trial NCT00764504: Reverse Shoulder Prosthesis Study
Official title: Encore Reverse Shoulder Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotator Cuff Arthropathy
Failed Total Shoulder
Failed Hemi-arthroplasty
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: American Shoulder and Elbow Surgeons Shoulder Score
timeFrame: 2-year
measure: Average Range of Motion
timeFrame: 2-year
measure: Subject Satisfaction With Surgery
timeFrame: 2-year
measure: Have Surgery Again?
timeFrame: 2-year
measure: Neer's "Limited Goals"
timeFrame: 2-year
measure: Radiographic Failures
timeFrame: Post-operative, 3-month, 6-month, 1-year, 2-year
measure: Safety Assessment
timeFrame: 2-year
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arthritis Orthopedics and Sports Medicine
state: California
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Ft. Collins
country: United States
facility: Orthopedic Center of the Rockies
state: Colorado
city: Lonetree
country: United States
facility: Advanced Orthopedic and Sports Medicine Specialists, P.C.
state: Colorado
city: Vail
country: United States
facility: Steadman Hawkins SPT Medical Foundation
state: Colorado
city: Atlantis
country: United States
facility: Atlantis Orthopaedics
state: Florida
city: Jupiter
country: United States
facility: Orthopaedic Surgery & Sports Medicine
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Orthopaedic Institute
state: Florida
city: Temple Terrace
country: United States
facility: Florida Orthopedic Institute
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Crestview
country: United States
facility: Cincinnati Sports Medicine & Orthopaedic Center
state: Kentucky
city: Lutherville
country: United States
state: Maryland
city: Towson
country: United States
facility: Orthopedic Specialists
state: Maryland
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Chapel Hill
country: United States
facility: UNC School of Medicine
state: North Carolina
city: Akron
country: United States
facility: Crystal Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Bone & Joint Hospital, LLC
state: Oklahoma
city: Spartanburg
country: United States
facility: Orthopedic Research Foundation of the Carolinas
state: South Carolina
city: Dallas
country: United States
facility: The Carrell Clinic
state: Texas
city: Dallas
country: United States
facility: Orthopedic Associates of Dallas
state: Texas
city: Ft. Worth
country: United States
facility: Orthopedic Specialty Associates, P.A.
state: Texas
city: San Antonio
country: United States
facility: Unlimited Research
state: Texas
city: Tyler
country: United States
facility: Orthopedic Institute
state: Texas
Study officials:
affiliation: Florida Orthopedic Institute
name: Mark Frankle, M.D.
role: PRINCIPAL_INVESTIGATOR
References: