Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

Launched by ARTHRO MEDICS AG · Aug 25, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new type of shoulder surgery called SMR Stemless Reverse Shoulder Arthroplasty. This procedure is designed for patients with certain shoulder problems, specifically those with rotator cuff tear arthropathy or osteoarthritis. The goal of the study is to see how well this surgery works over at least two years, looking at factors like pain relief, shoulder function, and any complications that might arise after the surgery.

To participate in this trial, patients need to be between the ages of 65 and 74, and they must have a diagnosis of rotator cuff arthropathy or osteoarthritis. They also need to provide written consent to join the study. However, women who are pregnant, nursing, or planning to become pregnant cannot take part, nor can anyone who has specific medical conditions that would prevent the use of this type of surgery. If eligible, participants can expect regular follow-up appointments to monitor their progress and gather information about their recovery and any issues that may occur.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • rotator-cuff arthropathy, osteoarthritis
• • approving written informed consent
• Exclusion Criteria:
• • Female patients who are pregnant, nursing, or planning a pregnancy.
• • All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
• • not consenting in participating in this study