Actively Recruiting
ACE Acetabular Cup UK Multi-centre PMCF Study
Led by JRI Orthopaedics · Updated on 2025-09-03
225
Participants Needed
1
Research Sites
647 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, and involves replacing both the hip ball and socket. Its goal is to provide pain relief, allowing the person to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has a H-A.C. coating to promote ossoeintegration of the device within the host bone. To increase the surgeons choice and thus suitability for the patient, there is the option of 3 different socket liners (ceramic, polymer or dual mobility). To ensure maximum safety and performance of medical devices surveillance of the device should be carried out over the devices lifetime. This study is a 10 year surveillance study to assess the clinical, functional and radiological outcomes of the CE-marked ACE Acetabular Cup System. This is done by examining patient outcomes through questionnaires, reviews of X-rays and complications by patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.
CONDITIONS
Official Title
ACE Acetabular Cup UK Multi-centre PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients deemed suitable for elective primary THR, as per indications in the IFU.
- Male or female, 18 years or older.
You will not qualify if you...
- 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 who are pregnant (exclusion criteria for THR in general).
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals Sussex NHS Foundation Trust
Worthing, United Kingdom, BN11 2DH
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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