Evaluating the Zimmer Biomet Shoulder Replacement System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study aims to assess the safety and performance of the Zimmer Biomet Shoulder Arthroplasty systems in patients undergoing primary anatomic shoulder arthroplasty. The study will monitor adverse events and evaluate improvements in pain, functional performance, quality of life, and radiographic parameters over a two-year period. The primary endpoint focuses on the American Shoulder and Elbow Surgeons (ASES) shoulder score, while secondary endpoints will further assess safety and overall patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient must be 20 years of age or older.
* Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
* Patient is a candidate for shoulder arthroplasty due to one or more of the following:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

Rheumatoid arthritis. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.

Difficult clinical management problems, where other method of treatment may not be suitable or may be inadequate.

* 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.

Exclusion Criteria:

* 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).
* Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
* Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
* Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
* Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable.
* Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device.
* Patient has a metabolic disorder that may impair bone formation.
* Patient has osteomalacia.

Where it's running

• ARCUS Kliniken Pforzheim
  Pforzheim, Germany Recruiting
• Meander Medisch Centrum
  Amersfoort, Tz, Netherlands Recruiting

Study contacts

• Study coordinator: Carina Hafner
• Email: carina.hafner@zimmerbiomet.com
• Phone: +41 79 707 30 93

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating Zimmer Biomet Shoulder Replacement Systems

  This study is testing how safe and effective Zimmer Biomet Shoulder Replacement Systems are for people getting shoulder surgery, looking at how well the implants last over ten years and how patients feel after two years.

  Recruiting at 2 sites Zimmer Biomet · Irvine, California and 16 other locations · NCT04984291

• Functional electrical stimulation plus shoulder exercises for older adults with rotator cuff pain

  In older adults with rotator cuff–related shoulder pain, this study tests whether adding functional electrical stimulation to a shoulder exercise program improves muscle coordination and reduces impingement compared with exercises alone.

  Recruiting University of Texas at Austin · Austin, Texas · NCT07886827

• Shoulder pain patients: see if breathing and chest exercises help pain and sleep

  This study tests whether adding respiratory muscle strengthening and diaphragmatic breathing to shoulder rehab can reduce pain and improve sleep in adults with chronic shoulder pain.

  Recruiting Zonguldak Bulent Ecevit University · Zonguldak · NCT07885215

• Night Pain Module for Rotator Cuff-Related Shoulder Pain

  Researchers are testing a short set of questions to measure night pain in people with rotator cuff–related shoulder pain to see if it reliably describes how sleep is affected.

  Recruiting at 3 sites Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Istanbul and 2 other locations · NCT07838233

• Nociplastic Pain in SAPS: A Look at Pain Types in Shoulder Pain

  This study tests how common nociplastic pain is among people with subacromial pain syndrome who have shoulder pain for at least 3 months.

  Recruiting Vejle Hospital · Vejle · NCT07792434

• Pain phenotype and response to corticosteroid injection in SAPS

  This study tests whether people with subacromial pain syndrome who have a nociplastic pain pattern respond differently to a corticosteroid injection than those without that pattern.

  Recruiting Vejle Hospital · Vejle · NCT07792421

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.