Zimmer Biomet Shoulder Arthroplasty PMCF Study

NCT06920459 | Recruiting

• 1 other identifier: CMU2019-35E-EU
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Shoulder Fractures; Shoulder Arthritis Osteoarthritis; Shoulder Injury; Shoulder Pain; Degenerative Joint Disease; Arthritis Shoulder

Keywords

medical device; PMCF; Anatomic Total Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Frequency and Incidence of Adverse Events (Safety)

  10 years

• Euroqol Patient Quality of life (EQ-5D-5L)

  10 years

• Radiographic Performance

  10 years

Study Arms (1)

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

Interventions

Alliance™ Glenoid DEVICE

Total Shoulder Arthroplasty using the Alliance™ Glenoid implant

Zimmer Biomet Total Shoulder Arthroplasty System

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

ARCUS Kliniken Pforzheim

Pforzheim, 75179, Germany

ACTIVE NOT RECRUITING

Meander Medisch Centrum

Amersfoort, TZ, 3813, Netherlands

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures; Shoulder Injuries; Shoulder Pain; Joint Diseases

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Arthralgia; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emilie Rohmer

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Carina Hafner

CONTACT

+41 79 707 30 93; carina.hafner@zimmerbiomet.com

Lisa To

CONTACT

Lisa.To@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2036
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

NL (1); DE (1)