ACE Acetabular Cup UK Multi-centre PMCF Study

Launched by JRI ORTHOPAEDICS · Oct 9, 2019

Keywords

ClinConnect Summary

The ACE Acetabular Cup UK Multi-centre PMCF Study is looking at a new hip replacement device called the ACE Acetabular Cup System. This study aims to see how well this device works and how safe it is over a period of 10 years. The device helps replace the hip joint to relieve pain and help people return to their normal activities. It has a special coating that helps it bond with the bone and comes with different options for the socket liner, which can be made of ceramic, polymer, or a combination of both.

To join the study, participants need to be at least 18 years old and be suitable for a total hip replacement (THR). Specifically, they should not have had any trauma-related hip injuries or be unable to provide consent. During the study, participants will fill out questionnaires, have their X-rays reviewed, and report any complications they may experience after receiving the hip replacement. This will help researchers understand how well the ACE Acetabular Cup System performs in real-world settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients deemed suitable for elective primary THR, as per indications in the IFU.
• • Male or female, 18 years or older.
• Exclusion Criteria:
• • Patients who are unable to provide written informed consent.
• • Patients deemed unsuitable for THR, as per contra-indications in the IFU.
• • Patients indicated for THR as a result of trauma (i.e. neck of femur fracture).
• • Patients receiving implants other than the approved combination, i.e. an ACE Acetabular Cup System with a JRI femoral stem and head.
• • Patients who are unable to comply with the protocol.