About this trial

This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.

Eligibility criteria

Qualifiers

Patient must be 20 years of age or older.

Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.

Patient must be able and willing to complete the protocol required follow-up.

Patient must be able and willing to sign the IRB/EC approved informed consent.

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

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

2
Germany
ARCUS Kliniken Pforzheim75179, Pforzheim Germany
Netherlands
Meander Medisch Centrum3813, AmersfoortTZ, Netherlands

Sponsors and collaborators

Zimmer Biomet

Lead sponsor