Who is eligible for clinical trial NCT07421245?

Participants must meet protocol criteria for Shoulder Injuries. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07421245 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-08

OsseoFit Stemless Shoulder System (Anatomic) (NCT07421245)

🟡 Not Yet Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Zimmer Biomet

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (21 items).

Location: Summit Medical Group P.A. dba Summit — Florham Park, New Jersey

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗