OsseoFit Stemless Shoulder System (Anatomic)

Starting soon

Conditions studied: Shoulder Injuries, Shoulder Pain, Shoulder Fractures, Shoulder Arthritis, Shoulder Disease

In brief

The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.

Key facts

Study ID

NCT07421245

Run by

Zimmer Biomet

People needed

136

Starts

2026-07-01

Expected to finish

2036-01-01

Last updated by the study team

2026-07-09

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be 20 years of age or older.
• The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
• Patient planned to receive OsseoFit™ anchor with uncemented fixation.
• Patient planned to receive a Modular Alliance Glenoid with bone cement. The porous posts must be coated with Porous Plasma Spray (PPS) and may be inserted without bone cement.
• Patient planned to receive shoulder arthroplasty due to osteoarthritis.
• Patient must be able and willing to complete the protocol required follow-up schedule.
• Patient must be able and willing to sign the IRB approved 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 participant (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 neuromuscular disease compromising the affected limb.
• Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include:
• Local/systemic infection
• Sepsis
• Osteomyelitis
• Patient presents with Osteomalacia.
• Patient presents with a humeral bone fracture.
• Patient presents with malunion or non-union of the tuberosities of the proximal humerus.
• Patient has had a previous operative shoulder prosthesis (stem or stemless).
• Patient has irreparable cuff tear.
• Patient presents with inadequate humeral bone, which in the opinion of the Investigator, may lead to poor implant fixation. This may include but is not limited to:
• Osteoporosis
• Extensive Avascular Necrosis
• Rheumatoid Arthritis
• Metaphyseal bony defects (including large cysts)

Where it is running

• Summit Medical Group P.A. dba Summit — Florham Park, New Jersey, United States
• The Research Foundation for the State University of New York — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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