Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty

Launched by ZIMMER BIOMET · Oct 30, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a specific type of shoulder replacement surgery using a new device called the Comprehensive Reverse Shoulder System. The goal is to see how safe and effective this system is for people with serious shoulder problems, such as severe arthritis or a damaged rotator cuff, especially in cases where previous shoulder surgeries have not worked well. This study involves multiple medical centers and is focused on patients who are 18 years or older and have a suitable shoulder structure to receive the implants.

To participate, patients should have significant shoulder issues, like a severely damaged rotator cuff or a failed shoulder replacement, and they must be able to follow the study's requirements and provide informed consent. Participants will have regular follow-ups to monitor their progress after the surgery. It’s important to note that individuals with certain conditions, such as osteoporosis or infections, will not be eligible to join the study. Overall, this trial aims to provide valuable information about this new shoulder surgery technique to help improve outcomes for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient must be 18 years of age or older.
• • Patient must be anatomically and structurally suited to receive the implants and possess a functional deltoid.
• • Patient must have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.
• • Patient must be able and willing to complete the protocol required follow-up.
• • Patient must be able and willing to sign the Institutional Review Board/Ethics Committee approved informed consent.
• Exclusion Criteria:
• • Patient is a prisoner.
• • Patient is a current alcohol or drug abuser.
• • Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
• • Patient presents with osteoporosis.
• • Patient has a metabolic disorder that may impair bone formation.
• • Patient has osteomalacia.
• • Patient has distant foci of infections which may spread to the implant site.
• • Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.