Evaluating Zimmer Biomet Shoulder Replacement Systems

Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study

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.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 584 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Zimmer Biomet (Industry-sponsored)
• Locations: 17 sites (Irvine, California and 16 other locations)
• Trial ID: NCT04984291 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 20 and older with conditions such as shoulder arthritis, fractures, or deformities that necessitate shoulder arthroplasty.

Not a fit: Patients with contraindications for shoulder arthroplasty or those who do not have functional deltoid muscles may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and quality of life for patients undergoing shoulder arthroplasty.

How similar studies have performed: Previous studies on shoulder arthroplasty systems have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility criteria

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 this trial is running

Irvine, California and 16 other locations

• Hoag Orthopedic Institute — Irvine, California, United States (Active_not_recruiting)
• Panorama Orthopaedic and Spine Center — Golden, Colorado, United States (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)
• TRIA Orthopaedic Center Research Institute — Bloomington, Minnesota, United States (Active_not_recruiting)
• Mississippi Sports Medicine and Orthopaedic Center, PLLC — Jackson, Mississippi, United States (Active_not_recruiting)
• Advance Bone and Joint — City of Saint Peters, Missouri, United States (Active_not_recruiting)
• Washington University — St Louis, Missouri, United States (Active_not_recruiting)
• University of Buffalo — Buffalo, New York, United States (Active_not_recruiting)
• Rothman Institute — Philadelphia, Pennsylvania, United States (Active_not_recruiting)
• Intermountain Health — Murray, Utah, United States (Recruiting)
• Fukui General Hospital — Fukui, Japan (Active_not_recruiting)
• Iwaki City Medical Center — Fukushima, Japan (Active_not_recruiting)
• Yuuai Medical Center — Okinawa, Japan (Active_not_recruiting)
• Kichijoji Minami Hospital — Tokyo, Japan (Withdrawn)
• Kensington Private Hospital — Whangarei, New Zealand (Withdrawn)

Study contacts

• Study coordinator: Cayla Lafollette, BS

Conditions Shoulder Fractures; Shoulder Arthritis; Shoulder Osteoarthritis; Shoulder Deformity; Shoulder Injuries; Shoulder Pain; Total Shoulder Arthroplasty; Glenoid