NCT04123431 ACE Acetabular Cup UK Multi-centre PMCF Study
| NCT ID | NCT04123431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | JRI Orthopaedics |
| Condition | Hip Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2023-06-06 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2023-06-06 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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.
Frequently Asked Questions
Who can join the NCT04123431 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04123431 currently recruiting?
Yes, NCT04123431 is actively recruiting participants. Visit ClinicalTrials.gov or contact JRI Orthopaedics to inquire about joining.
Where is the NCT04123431 trial being conducted?
This trial is being conducted at Worthing, United Kingdom.
Who is sponsoring the NCT04123431 clinical trial?
NCT04123431 is sponsored by JRI Orthopaedics. The trial plans to enroll 225 participants.