Hi-Fatigue G Bone Cement Retrospective Study

Launched by ZIMMER BIOMET · Nov 19, 2024

Keywords

ClinConnect Summary

The Hi-Fatigue G Bone Cement Retrospective Study is looking into the safety and effectiveness of a special type of bone cement used in total hip and knee replacement surgeries. Researchers want to understand how well this cement performs over time, specifically checking if there are any issues with the implants and how satisfied patients feel after their surgeries. They will review medical images and gather feedback from patients to see how the cement works and if it affects the longevity of the implants.

To be eligible for this study, participants need to be over 18 years old and qualify for a cemented total knee or hip replacement using a specific type of implant. They will need to provide consent for doctors to use their past medical data, which includes X-rays and pain scores. Participants should be able to communicate effectively and not have certain health issues, like severe kidney problems or muscle wasting. If you join the study, you can expect to help researchers gather important information that could improve future surgeries and patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject qualified for cemented TKA or THA with a Zimmer Biomet implant
• • Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray \& Scores completion)
• • Subject \> 18 years old
• Exclusion Criteria:
• • Muscle wasting
• • Neuromuscular compromise in the affected limb
• • Known hypersensitivity to any of the cement constituents
• • Subjects with severe renal failure
• • Bilateral interventions
• • Subject is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, known alcohol or drug abuser, anticipated to be non-compliant)