The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.
Patient must be 20 years of age or older.
Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Patient is unwilling or unable to give consent or to comply with the follow-up program.
Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
Patient is known to be pregnant or breastfeeding.
Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
Single group
Alliance Glenoid
DeviceAlliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty
Identity Stem
DeviceIdentity Shoulder System is intended to be used in anatomic total shoulder arthroplasty, shoulder hemi-arthroplasty, or total reverse shoulder arthroplasty in both Primary or Revision Total Shoulder Arthroplasty
Implant Survivorship at 10 years follow-up (Kaplan Meier)
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Frequency and Incidence of Adverse Events (Safety)
Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 2 years follow-up
Pain, function, and activities of daily living are measured. The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)
The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.
Radiographic Performance [Radiolucency] at 2 years follow-up
X-rays will be evaluated for radiolucency lines to show the number of subjects with radiolucency. Radiolucency refers to structures that are less dense and permit the x-ray beam to pass through them. Radiolucent structures appear dark or black in the radiographic image.
Radiographic Performance [Osteolysis] at 2 years follow-up
X-rays will be evaluated for osteolysis to show the number of subjects with osteolysis. Osteolysis is a progressive condition where bone tissue is destroyed. In this process, bones lose minerals (mostly calcium), softens, degenerates and become weaker.
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