Evaluating Zimmer Biomet Shoulder Replacement Systems

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 study aims to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems in patients undergoing primary or revision shoulder arthroplasty. The primary endpoint focuses on the survival of the implant over a 10-year period, while secondary endpoints assess performance and clinical benefits after 2 years using standardized scoring systems. Adverse events will be monitored to evaluate the safety of the system, and separate analyses will be conducted for each arm of the study.

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.
  * Correction of functional deformity.
  * Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
  * Difficult clinical management problems, where other methods 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.
* Patient has grossly deficient rotator, (for reverse application)

  * With severe arthropathy and/or
  * Previously failed shoulder joint replacement
* Patient must have functional deltoid muscle (for reverse application)

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 osteomalacia.
* Patient has a metabolic disorder that may impair bone formation.
* Patient has deficient rotator cuff.
* Patient presents with significant injury to the upper brachial plexus.
* Patient has paralysis of the axillary nerve.
* Patient has non-functional deltoid or external rotator muscles.

Where it's running

• Panorama Orthopaedic and Spine Center
  Golden, Colorado, United States Recruiting
• Intermountain Health
  Murray, Utah, United States Recruiting
• Hoag Orthopedic Institute
  Irvine, California, United States Active not recruiting
• Northwestern University
  Chicago, Illinois, United States Active not recruiting
• Norton Healthcare, Inc
  Louisville, Kentucky, United States Terminated
• William Beaumont Hospital
  Royal Oak, Michigan, United States Active not recruiting

Study contacts

• Study coordinator: Cayla Lafollette, BS
• Email: Cayla.lafollette@zimmerbiomet.com
• Phone: 574 268-8610

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

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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.