About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Alliance Glenoid
  • Identity Stem

Treatment groups

584 Participants
are divided into 1 treatment group

Locations

17
Japan
Fukui General Hospital910-3113, Fukui Japan
Iwaki City Medical Center973-8555, Fukushima Japan
Yuuai Medical Center901-0224, Okinawa Japan
Kichijoji Minami Hospital180-0003, Tokyo Japan

Sponsors and collaborators

Zimmer Biomet

Lead sponsor