OsseoFit Stemless Shoulder System (Anatomic) Post-Market Clinical Follow-up Study
Zimmer Biomet
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.
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 S…
Eligibility
- Age range
- 20+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 follo…
Interventions
- DeviceOsseoFit Stemless Inlay
Inlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone.
- DeviceOsseoFit Stemless Onlay
The Onlay implants sit on top of the prepared bone.
Location
- The Research Foundation for the State University of New YorkBuffalo, New York