MDR - Comprehensive Primary Revision Stems PMCF

Launched by ZIMMER BIOMET · Jan 17, 2025

Keywords

ClinConnect Summary

The MDR - Comprehensive Primary Revision Stems study is looking at the long-term safety and effectiveness of a specific type of shoulder implant used during surgeries for conditions like shoulder pain, injuries, fractures, and arthritis. Researchers will gather data over several years—at 1, 3, 5, 7, and 10 years—to see how well these implants perform and what benefits they provide to patients.

To participate in this study, you need to be at least 18 years old and willing to follow instructions. It's important that the shoulder implant was placed using the recommended surgical techniques. However, if you have a serious mental health condition, struggle with substance abuse, or cannot give informed consent, you wouldn’t be eligible to join. The study is not actively recruiting participants yet, but once it starts, those who qualify can expect to help researchers understand how these implants work over time, contributing to better shoulder care for future patients.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Patient must be 18 years of age or older.
• • Patient must be willing and able to follow directions.
• • Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem
• • Exclusion Criteria
• • Off-label use.
• • Patient is a prisoner.
• • Patient is a current alcohol or drug abuser.
• • Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
• • Patient is unwilling to sign informed consent.
• • Uncooperative patient or patient with neurologic disorders who are incapable of following directions.