Zimmer Biomet Shoulder Arthroplasty PMCF Study

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

This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Pain; Shoulder Fractures; Shoulder Injury; Arthritis Shoulder; Degenerative Joint Disease; Shoulder Arthritis Osteoarthritis
• Intervention / Treatment: Device: Alliance™ Glenoid

Detailed Description

The primary endpoint for this study will be performance assessed by improvement in the American Shoulder and Elbow Surgeons (ASES) shoulder score from baseline to 2 years (as evaluated using the overall cohort mean showing at least the minimal clinically important difference (MCID) of 6.4 points).

The secondary endpoint is represented by the safety of the system, which will be assessed by monitoring the frequency and incidence of adverse events. The secondary endpoint evaluation will also assess the overall pain, functional performance, quality of life and radiographic parameters of all enrolled study subjects.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Carina Hafner; Phone Number: +41 79 707 30 93; Email: carina.hafner@zimmerbiomet.com
• Study Contact Backup: Name: Lisa To; Email: Lisa.To@zimmerbiomet.com

Study Locations

• Germany
  • Pforzheim, Germany, 75179
    • Active, not recruiting
    • ARCUS Kliniken Pforzheim
• Netherlands
  • TZ
    • Amersfoort, TZ, Netherlands, 3813
      • Recruiting
      • Meander Medisch Centrum
      • Contact: Dr. T.D. Berendes; Phone Number: +31 33 850 4798; Email: poli_orthopedie@meandermc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The Alliance Glenoid is intended to be used as part of an anatomic total shoulder arthroplasty to reduce shoulder pain an improve shoulder function. The Alliance Glenoid is intended to be used as a component of a total shoulder replacement system for primary arthroplasty. It provides the surface on the glenoid side that articulates with the modular head component and stem component on the humeral side. Patients must meet all inclusion and none on the exclusion criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Zimmer Biomet Total Shoulder Arthroplasty System; Patients who are having primary total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System	Device: Alliance™ Glenoid; Total Shoulder Arthroplasty using the Alliance™ Glenoid implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons (ASES)	The primary endpoint for this study will be performance assessed by improvement in the American Shoulder and Elbow Surgeons (ASES) shoulder score from baseline to 2 years (as evaluated using the overall cohort mean showing at least the minimal clinically important difference (MCID) of 6.4 points). Pain, function, and activities of daily living are measured. The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and Incidence of Adverse Events (Safety)	Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.	10 years
Euroqol Patient Quality of life (EQ-5D-5L)	The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.	10 years
Radiographic Performance	X-Rays will be evaluated for radiolucency, osteolysis, osteophytes, component migration, subsidence and heterotopic ossification.	10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Emilie Rohmer, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2036

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: medical device; PMCF; Anatomic Total Shoulder Arthroplasty
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Wounds and Injuries; Fractures, Bone; Arthralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Injuries; Joint Diseases; Shoulder Pain; Shoulder Fractures
• Other Study ID Numbers: CMU2019-35E-EU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No