Zimmer Biomet Shoulder Arthroplasty PMCF

NCT04984291 | Recruiting FDA Device

• 1 other identifier: CMU2019-35E
• Study Type: interventional
• Target: 584
• Locations: 3 countries
• Sites: 17

Brief Summary

The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.

Conditions

Shoulder Fractures; Shoulder Arthritis; Shoulder Osteoarthritis; Shoulder Deformity; Shoulder Injuries; Shoulder Pain

Keywords

Total Shoulder Arthroplasty; Glenoid; Humeral Stem; Stem Adapter; Humeral Head; Humeral Bearing; Humeral Trays; Head Adapter; Reverse; Anatomic; Hemi

Outcome Measures

Primary Outcomes (2)

• Implant Survivorship at 10 years follow-up (Kaplan Meier)

  Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

  10 years

• 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

Secondary Outcomes (7)

• Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 2 years follow-up

  2 years

• Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)

  2 years

• Radiographic Performance [Radiolucency] at 2 years follow-up

  2 years

• Radiographic Performance [Osteolysis] at 2 years follow-up

  2 years

• Radiographic Performance [Heterotopic Ossification] at 2 years follow-up

  2 years

Study Arms (1)

Zimmer Biomet Total Shoulder Arthroplasty System

EXPERIMENTAL

Patients who are having primary or revision total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System.

Device: Alliance Glenoid; Device: Identity Stem

Interventions

Alliance Glenoid DEVICE

Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty

Also known as: Alliance

Zimmer Biomet Total Shoulder Arthroplasty System

Identity Stem DEVICE

Identity Shoulder System is intended to be used in anatomic total shoulder arthroplasty, shoulder hemi-arthroplasty, or total reverse shoulder arthroplasty in both Primary or Revision Total Shoulder Arthroplasty

Also known as: Identity

Zimmer Biomet Total Shoulder Arthroplasty System

Eligibility Criteria

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

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.
• 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)

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 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (17)

Hoag Orthopedic Institute

Irvine, California, 92618, United States

ACTIVE NOT RECRUITING

Panorama Orthopaedic and Spine Center

Golden, Colorado, 80401, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60208, United States

ACTIVE NOT RECRUITING

Norton Healthcare, Inc

Louisville, Kentucky, 40202, United States

TERMINATED

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

ACTIVE NOT RECRUITING

TRIA Orthopaedic Center Research Institute

Bloomington, Minnesota, 55431, United States

ACTIVE NOT RECRUITING

Mississippi Sports Medicine and Orthopaedic Center, PLLC

Jackson, Mississippi, 39202, United States

ACTIVE NOT RECRUITING

Advance Bone and Joint

City of Saint Peters, Missouri, 63376, United States

ACTIVE NOT RECRUITING

Washington University

St Louis, Missouri, 63130, United States

ACTIVE NOT RECRUITING

University of Buffalo

Buffalo, New York, 14215, United States

ACTIVE NOT RECRUITING

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

ACTIVE NOT RECRUITING

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

Fukui General Hospital

Fukui, 910-3113, Japan

ACTIVE NOT RECRUITING

Iwaki City Medical Center

Fukushima, 973-8555, Japan

ACTIVE NOT RECRUITING

Yuuai Medical Center

Okinawa, 901-0224, Japan

ACTIVE NOT RECRUITING

Kichijoji Minami Hospital

Tokyo, 180-0003, Japan

WITHDRAWN

Kensington Private Hospital

Whangarei, 0112, New Zealand

WITHDRAWN

MeSH Terms

Conditions

Shoulder Fractures; Shoulder Injuries; Shoulder Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Ryan Boylan

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Cayla Lafollette, BS

CONTACT

574 268-8610; Cayla.lafollette@zimmerbiomet.com

Ryan Boylan, MBA

CONTACT

ryan.boylan@zimmerbiomet.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 30, 2021
• Study Start: July 28, 2021
• Primary Completion (Estimated): August 15, 2033
• Study Completion (Estimated): August 15, 2033
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (12); JP (4); NZ (1)