OsseoFit Stemless Shoulder System (Anatomic)
brief 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.
official title
OsseoFit Stemless Shoulder System (Anatomic) Post-Market Clinical Follow-up Study