Clinical trial NCT01790113: Arthrex Eclipse™ Shoulder Prosthesis
Official title: A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder Prothesis to the Univers™ II Shoulder Prosthesis in Patients With a Degenerative Joint Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 303
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a degenerative joint disease.

Detailed description: The purpose of this study is to demonstrate non-inferiority of the Arthrex Eclipse™ Shoulder Prosthesis to the Arthrex Univers™ II Shoulder Prosthesis for the treatment of degenerative joint disease in subjects who are candidates for total shoulder replacement. Non-inferiority in terms of safety and effectiveness will be measured by a 2 year composite clinical success (CCS) that requires functional improvement, radiographic success, absence of reoperations and revision, and lack of serious device-related adverse events.

Eligibility criteria: Inclusion Criteria:

* The subject is \> 21 years of age
* The subject has continued symptoms in target shoulder despite at least 3 months of other treatment modalities(e.g.: anti-inflammatory, physical therapy and steroid injections)
* The subject has a diagnosis in the target shoulder of one or more of the following:

osteoarthritis, avascular necrosis, post-traumatic arthritis, or rheumatoid arthritis.

* The subject presents with pain and functional impairment in the index shoulder, measured by an Adjusted Constant Score of ≤50. Note: The Adjusted Constant Score will be calculated from the raw Constant Score to establish patient eligibility.
* The subject is willing to receive implantation of the Arthrex™ Shoulder Prosthesis or Univers™ II Shoulder Prosthesis.
* The subject must be physically and mentally willing and able to comply with all study procedures (including follow-up visits and radiographic assessments) until the conclusion of the study.
* The subject has been informed of the nature of the study and provided written consent as approved by the sites local Institutional Review Board or Ethic Review Board.

Exclusion Criteria:

* The subject is likely a candidate for hemi-humeral arthroplasty (i.e.: Avascular Necrosis of the humeral head without glenoid involvement (Stages 0-3): Rotator Cuff Deficient Shoulder: Glenoid Bone deficiency/deformity that precludes glenoid replacement (Walch Type B2 or C) or Fractures of the Proximal Humerus, without Glenoid involvement.
* The subject has immature bone as defined by the absence of cancellous bone patterning, a mature, thick cortex, and stress lines within the cancellous bone.
* The subject has obvious defects in bone quality, such as cysts or lesions, in the humeral head of the target shoulder, as demonstrated by radiographic evaluation.
* The subject has a target shoulder a rotator cuff that is not intact and not reconstructible.
* The subject has Irreducible 3- and 4- part proximal humeral fractures of the target shoulder.
* The subject has documented history of foreign-body sensitivity.
* Subject with positive pregnancy test, or lactating, or intends to become pregnant during treatment period
* The subject has history of Schizophrenia, Bipolar Disorder and/or Major Depressive Disorder as defined by DSM IV.
* The subject is skeletally immature demonstrated radiographically by incomplete closure of proximal humeral epiphyses.
* The subject is at high risk for poor healing or confounding outcomes \[(i.e.: clinically significant renal, hepatic, cardiac hematologic disease or endocrine disease)\]
* The subject is on immune-stimulating or immunosuppressive agents
* The subject has co-morbidity that reduces life expectancy \< 36 month.
* The subject seeking or receiving workman's compensation for shoulder injury,
* The subject is \> 350 lbs.
* The subject engaged in heavy labor (e.g. repetitive lifting in the excess of more than 50 lbs.)
* The subject has had surgery in the affected shoulder in the last 12 months (with the exception of diagnostic arthroscopy without reconstruction or repair procedures)
* The subject is engaged in active sports participation. (e.g. weight lifting involving upper extremities or involved in contact sports)
* The subject is taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids with the exception of topical and/or inhalers)
* The subject is a prisoners or wards of the state
* The subject has a history of alcohol and/or substance abuse as defined by DSM IV (Diagnostic and Statistical Manual Diploma in Social Medicine)
* The subject has an active or chronic infection, either systemic or local.
* The subject has pathologic fractures of the affected shoulder
* The subject has acute trauma of the affected shoulder
* The subject has osteoporosis defined as a bone density T score of \< or = -2.5. (A screening Questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) and MORES (Male Osteoporosis Risk Estimation Score), will be used to screen patients who require a DEXA (dual energy x-ray absorptiometry) bone mineral density measurement.

Primary outcomes:
measure: Composite Clinical Success
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Research
state: Arizona
city: Redwood City
country: United States
facility: Orthopedics Stanford University
state: California
city: Denver
country: United States
facility: Western Orthopaedics
state: Colorado
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Louisville
country: United States
facility: Ellis and Badenhausen Orthopedics PSC
state: Kentucky
city: Hyattsville
country: United States
facility: Medstar Health Research Institute
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Orthopaedics Associates, P.A.
state: Maryland
city: Duluth
country: United States
facility: Essentia Health Duluth
state: Minnesota
city: Amherst
country: United States
facility: Excelsior Orthopedics
state: New York
city: East Syracuse
country: United States
facility: SUNY Upstate Medical Universtiy
state: New York
city: Chillicothe
country: United States
facility: Adena Health System
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute at Grant Medical Center
state: Ohio
city: Medford
country: United States
facility: Southern Oregon Orthopedics
state: Oregon
city: Altoona
country: United States
facility: University Orthopedics
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health Orthopedics (formerly Providence Orthopedics Group, LLC_Moore Orthopedics)
state: South Carolina
Study officials:
affiliation: Arthrex, Inc.
name: Melissa Hirschberg
role: STUDY_DIRECTOR
References: