Arthrex Eclipse™ Shoulder Prosthesis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01790113|
Recruitment Status : Terminated (Eclipse Shoulder System received 510(k) clearance on July 26, 2019.)
First Posted : February 13, 2013
Results First Posted : January 29, 2021
Last Update Posted : February 3, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Univers™ Device: Eclipse™ Total Shoulder Replacement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||303 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 4, 2013|
|Actual Primary Completion Date :||June 7, 2019|
|Actual Study Completion Date :||June 7, 2019|
Active Comparator: Univer™ II
Univers™ II Total Shoulder Replacement
Eclipse™ Total Shoulder Replacement
Device: Eclipse™ Total Shoulder Replacement
- Composite Clinical Success [ Time Frame: 2 year ]
To be considered a success, the eclipse subject must meet the following composite clinical success criteria:
- An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is > or = to 10 and a final Adjusted Constant Score > or + to 54.
- Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol.
- No reoperation, removal or modification of any study component up to the subject's completion of the study.
- No serious device-related complications up to the subject's completion of the study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790113
|United States, Arizona|
|Sun City, Arizona, United States, 85351|
|United States, California|
|Orthopedics Stanford University|
|Redwood City, California, United States, 94063|
|United States, Colorado|
|Denver, Colorado, United States, 80218|
|United States, Illinois|
|Midwest Orthopaedics at Rush|
|Chicago, Illinois, United States, 60612|
|United States, Kentucky|
|Ellis and Badenhausen Orthopedics PSC|
|Louisville, Kentucky, United States, 40223|
|United States, Maryland|
|Medstar Health Research Institute|
|Hyattsville, Maryland, United States, 20782|
|Peninsula Orthopaedics Associates, P.A.|
|Salisbury, Maryland, United States, 21804|
|United States, Minnesota|
|Essentia Health Duluth|
|Duluth, Minnesota, United States, 55805|
|United States, New York|
|Amherst, New York, United States, 14226|
|SUNY Upstate Medical Universtiy|
|East Syracuse, New York, United States, 13057|
|United States, Ohio|
|Adena Health System|
|Chillicothe, Ohio, United States, 45601|
|OhioHealth Research Institute at Grant Medical Center|
|Columbus, Ohio, United States, 43215|
|United States, Oregon|
|Southern Oregon Orthopedics|
|Medford, Oregon, United States, 97504|
|United States, Pennsylvania|
|Altoona, Pennsylvania, United States, 16602|
|Philadelphia, Pennsylvania, United States, 19108|
|United States, South Carolina|
|Palmetto Health Orthopedics (formerly Providence Orthopedics Group, LLC_Moore Orthopedics)|
|Columbia, South Carolina, United States, 29203|
|Study Director:||Melissa Hirschberg||Arthrex, Inc.|
Documents provided by Arthrex, Inc.:
|Responsible Party:||Arthrex, Inc.|
|Other Study ID Numbers:||
|First Posted:||February 13, 2013 Key Record Dates|
|Results First Posted:||January 29, 2021|
|Last Update Posted:||February 3, 2021|
|Last Verified:||October 2019|