Trial Search Results
Arthrex Eclipse™ Shoulder Prosthesis
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.
Stanford is currently accepting patients for this trial.
- Device: Univers™
- Device: Eclipse™ Total Shoulder Replacement
- 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
- 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.
- 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
- 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
- The subject has Irreducible 3- and 4- part proximal humeral fractures of the target
- 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
- 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
- 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
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study