What is Zimmer Biomet studying for shoulder conditions?

Zimmer Biomet is studying the safety, performance, and clinical benefits of its shoulder arthroplasty systems for patients needing shoulder replacement surgery. The study aims to understand how well the implant lasts over time and how it affects shoulder function and quality of life. This research helps improve treatment options for shoulder arthritis, fractures, and related conditions.

Who may be eligible for this shoulder arthroplasty clinical trial?

Adults aged 20 years or older with shoulder conditions requiring arthroplasty, including osteoarthritis, rheumatoid arthritis, or certain fractures, may be eligible. Participants must be able to complete follow-up visits and give informed consent. People with infections in the shoulder area or certain neuromuscular diseases may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this shoulder arthroplasty clinical trial?

Study-related care, including the implant device and all study visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 20Years +

All Genders

ID04984291

Long-Term Study on Zimmer Biomet Shoulder Arthroplasty Systems for Treating Shoulder Conditions

Led by Zimmer Biomet · Updated on 2026-04-28

584

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instruments in patients undergoing primary or revision shoulder arthroplasty. The study aims to confirm implant survival over 10 years, monitor adverse events, and assess improvements in shoulder function, pain, quality of life, and radiographic outcomes using standard scoring systems and imaging. Participants will receive the Zimmer Biomet Total Shoulder Arthroplasty System, including devices like the Alliance Glenoid and Identity Stem, designed for various types of shoulder replacements. The study will follow patients for 10 years to track implant survival and safety, with a 2-year evaluation focusing on clinical performance and radiographic measures. During the study, patients will undergo assessments of implant survival using the Kaplan Meier method, adverse event monitoring, and evaluations of shoulder function with the American Shoulder and Elbow Surgeons ASES score, quality of life questionnaires, and detailed radiographic imaging. Follow-up visits at 2 years and up to 10 years will help researchers understand the long-term results of the shoulder arthroplasty system.

CONDITIONS

Brief Title

Zimmer Biomet Shoulder Arthroplasty PMCF

Who Can Participate

Age: 20Years +

All Genders

Eligibility Criteria

You may qualify if you...

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 treatments are inadequate, or difficult clinical management problems.
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 cuff with severe arthropathy and/or previously failed shoulder joint replacement (for reverse application).
Patient must have functional deltoid muscle (for reverse application).

You will not qualify if you...

Patient is unwilling or unable to give consent or comply with the follow-up program.
Patient has any condition placing them at undue risk or interfering with the study, according to the Investigator.
Patient is known to be pregnant or breastfeeding.
Patient is a vulnerable subject such as prisoner, mentally incompetent, known alcohol or drug abuser, or anticipated to be non-compliant.
Patient is uncooperative or has neurologic disorders impairing ability to follow directions.
Patient has any infection affecting the shoulder joint or nearby area that may spread to the implant site.
Patient has rapid joint destruction, marked bone loss, or bone resorption seen on imaging.
Patient has neuromuscular disease compromising the affected limb making the procedure unjustifiable.
Patient has osteoporosis that limits support for the shoulder arthroplasty device.
Patient has osteomalacia.
Patient has a metabolic disorder impairing bone formation.
Patient has deficient rotator cuff.
Patient has significant injury to the upper brachial plexus.
Patient has paralysis of the axillary nerve.
Patient has non-functional deltoid or external rotator muscles.

Research Team

Cayla Lafollette, BS

Ryan Boylan, MBA

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Long-Term Study on Zimmer Biomet Shoulder Arthroplasty Systems for Treating Shoulder Conditions

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria