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.

Lead Sponsor:

Arthrex, Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: Univers™
  • Device: Eclipse™ Total Shoulder Replacement

Phase:

N/A

Eligibility


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.

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Handley
650-721-7614
Recruiting