NCT07421245

OsseoFit Stemless Shoulder System (Anatomic)

OsseoFit Stemless Shoulder System (Anatomic) Post-Market Clinical Follow-up Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 136 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The objectives of this study are to confirm the safety, performance, and clinical benefits of the OsseoFit Stemless Shoulder System (implants and instruments) in primary total shoulder arthroplasty (anatomic). Safety of the system 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, survivorship, quality of life, and radiographic parameters for all enrolled study participants. The primary endpoint is the improvement in the American Shoulder and Elbow Surgeons (ASES) Shoulder score between the pre-operative period (baseline) and 2 years of follow up. The key secondary endpoint is the survival of the implant system at 10 years, which is based on removal of any part of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. The secondary endpoint evaluation will also assess the overall pain/functional performance (ASES, Constant Murley Shoulder Score, and ROM), quality of life, satisfaction, and radiographic parameters of all enrolled study participants.

Conditions

• Shoulder Injuries
• Shoulder Pain
• Shoulder Fractures
• Shoulder Arthritis
• Shoulder Disease

Interventions

Type	Name	Description
DEVICE	OsseoFit Stemless Inlay	Inlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone.
DEVICE	OsseoFit Stemless Onlay	The Onlay implants sit on top of the prepared bone.

Timeline

• Start date: 2026-04-01
• Primary completion: 2036-01-01
• Completion: 2036-01-01
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study