Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device

Launched by FH ORTHO · Dec 6, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the ESOP 2 stem, a device used in total hip replacement surgeries for patients with hip diseases or hip fractures. The main goal of the study is to gather information about how safe and effective this device is over the long term when used in everyday situations. This research is important to ensure that the ESOP 2 stem performs well and meets the needs of patients after surgery.

To participate in this study, you need to have already received the ESOP 2 stem as part of your hip replacement surgery. You should also be able to understand and agree to take part in the study after receiving information about it. The study is open to all patients aged 65 and older who meet these criteria. If you join, you can expect to provide feedback and information about your experience with the device. Your participation will help improve the understanding of this device's long-term performance and safety for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject implanted with ESOP 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture
• • Subject who received an information form and is willing to participate in the study
• Exclusion Criteria:
• • Contraindications described in the instructions for use
• • Usual surgical contraindications
• • Subject who is not able to express his/her non-opposition