Long-Term Outcome Study of Shoulder Innovations Total Shoulder Arthroplasty Devices Observing Patients Receiving Anatomic or Reverse Shoulder Replacement

What this Trial Is About

Researchers are conducting a non-randomized, multi-center observational study to collect long-term clinical outcome data for patients who have received or plan to receive anatomic or reverse total shoulder arthroplasty using the Shoulder Innovations Total Shoulder System device. The study aims to evaluate both short-term and long-term real-world clinical and radiographic outcomes associated with the use of this shoulder replacement system over a period of up to 10 years after surgery. The study involves collecting standard-of-care data from patients who consent to participate and have at least one Shoulder Innovations device implanted. This includes monitoring the durability of the implant from the time of surgery through 10 years post-operation. Researchers will also assess changes in shoulder range of motion, and patient-reported outcomes using ASES, SANE, and PROMIS Global-10 scores at multiple timepoints from before surgery until 10 years after. Participants will be followed with clinical evaluations, radiographic imaging to check for implant stability and loosening, and assessments of adverse device effects or complications. Patient-reported outcome measures will be completed before surgery and at each postoperative visit. The total duration of participation may extend up to 10 years, allowing comprehensive monitoring of implant performance and patient recovery over time.

Shoulder Innovations Clinical Data Registry