Recruiting

Shoulder Arthroplasty

Sponsor:

Zimmer Biomet

Code:

NCT04984291

Conditions

Shoulder Fractures

Shoulder Arthritis

Shoulder Osteoarthritis

Shoulder Deformity

Shoulder Injuries

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Alliance Glenoid

Identity Stem

Study Details

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

Study ID

NCT04984291

Start date

Jul 28, 2021

Status verified date

Apr, 2026

Completion date

Aug 15, 2033

Anticipated

Primary completion date

Aug 15, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

584 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zimmer Biomet Total Shoulder Arthroplasty System

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

Interventions

Alliance Glenoid

Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty

Identity Stem

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

Primary outcome measure

  • Implant Survivorship at 10 years follow-up (Kaplan Meier) [ Time Frame: 10 years ]
  • Frequency and Incidence of Adverse Events (Safety) [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Cayla Lafollette, BS

574 268-8610Cayla.lafollette@zimmerbiomet.com

Ryan Boylan, MBA

ryan.boylan@zimmerbiomet.com

Locations

Panorama Orthopaedic and Spine Center

Recruiting

Golden, Colorado, United States, 80401

Contacts

Paul Lee, PA

720-497-6697ResearchCoordinators@panoramaortho.com

ResearchCoordinators@panoramaortho.com

Principal Investigator:

David Schneider, MD

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Contacts

Maha Maleki, BS

801-507-8095Maha.Maleki@imail.org

Matt Schneider, MS

801-507-8095Matthew.Schneider@imail.org

Principal Investigator:

Aaron Chamberlain, MD

More Information

Sponsor

Zimmer Biomet

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zimmer Biomet on 2026-04-28.