This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively. The study population includes adult patients who undergo reverse shoulder arthroplasty (RSA) or shoulder hemiarthroplasty (HA) using the Tipmed™ implant systems due to various clinical indications such as osteoarthritis, rotator cuff arthropathy, or proximal humerus fractures. The main objective is to gather real-world clinical evidence on the 12-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.
Individuals aged 18 years and older,
Male or female participants,
Participants who have undergone Reverse Shoulder Arthroplasty or Shoulder Hemiarthroplasty for any valid indication,
Participants in whose surgical procedure the Tipmed™ Shoulder Prosthesis System product configurations were utilized.
Concurrent participation in any other interventional clinical trial.
TIPMED Medical Device Manufacturing Ltd. Co.
Lead sponsor