Clinical trial NCT01005446: Reverse Shoulder Prosthesis Prospective Multi-Center Study
Official title: PS-901: Prospective Multicenter Open Label Study of the Encore Reverse® Shoulder Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Deficiency
Shoulder Arthropathy
Failed Shoulder Replacement
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
Collaborators: name: DJO Incorporated
First posted: 2009-11-01
Enrollment: 245
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

Detailed description: Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term. A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency. The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department. The study will include only subjects who meet the indications for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline
timeFrame: 2 year
Secondary outcomes:
measure: Radiologic Success
timeFrame: 5 year
measure: Change in ASES score from Baseline
timeFrame: 5 year
measure: SF36- (Short Form 36)Health Survey
timeFrame: 5 year
measure: Change in Simple Shoulder Test from Baseline
timeFrame: 5 year
measure: Subject Satisfaction Survey
timeFrame: 5 year
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University - Dept. of Orthopedics
state: California
city: Bradenton
country: United States
facility: Coastal Orthopedics & Sports Medicine
state: Florida
city: Fort Lauderdale
country: United States
facility: Orthopaedic Institute at Holy Cross Hospital
state: Florida
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: Louisville
country: United States
facility: Norton Orthopaedic & Sports Medicine Specialists
state: Kentucky
city: Amherst
country: United States
facility: Excelsior Orthopaedics
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Sports Medicine and Orthopeadic Center
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Plano
country: United States
facility: Texas Center for Joint Replacement
state: Texas
city: Saint George
country: United States
facility: Rimrock Orthopedics
state: Utah
Study officials:
affiliation: Cincinnati Sports Medicine and Orthopaedic Center
name: Samer S. Hasan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: