Recruiting

Long-term monitoring of shoulder replacement implant safety and performance

Plain-English translation of NCT06920459 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

What is this trial?

This is a follow-up study for patients receiving the Zimmer Biomet Total Shoulder Arthroplasty System — a shoulder replacement implant designed to treat conditions like arthritis, fractures, or severe shoulder damage. Researchers will track how well your shoulder works after surgery and watch for any safety concerns over the course of two years. The goal is to confirm that this implant performs well and remains safe for long-term use.

Even after a device is approved and used in patients, manufacturers are required to continue monitoring its real-world performance and safety. This study collects that ongoing information to make sure the implant continues to work as expected and to catch any rare or long-term problems early.

Do you qualify?

You likely qualify if…

you are 20 years old or older
you are having primary (first-time) total shoulder replacement surgery
you have a shoulder condition like osteoarthritis, rheumatoid arthritis, a proximal humerus fracture, or another shoulder injury where replacement is recommended
your shoulder anatomy and bone structure are suitable for a shoulder implant
you are willing and able to attend follow-up appointments for two years after surgery

You likely don't qualify if…

you are pregnant or breastfeeding
you have an active infection in or near your shoulder
you have severe bone loss or very rapid joint destruction visible on X-rays
you have significant osteoporosis or a metabolic bone disease that your doctor believes would make surgery unsafe
you have a neuromuscular disease affecting your arm that would make shoulder replacement inadvisable

What participation looks like

If you qualify, you will receive shoulder replacement surgery with the Zimmer Biomet implant as part of your standard care. You will then be asked to return for follow-up visits over the next two years, during which your doctor will assess your shoulder function, pain levels, and quality of life. You may also have X-rays taken to monitor the implant. Researchers will track how much your shoulder pain and function improve and watch for any adverse events or complications.

AI-generated summary from trial data · Jun 21, 2026 · Not medical advice

Trial locations(2 sites)

Germany

ARCUS Kliniken Pforzheim, Pforzheim

Netherlands

Meander Medisch Centrum, Amersfoort, TZ