ACE Acetabular Cup 10-year UK post-market follow-up
A Prospective UK Multi-Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System
This 10-year follow-up will see how well the ACE Acetabular Cup works and how patients feel after a primary total hip replacement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | JRI Orthopaedics Industry-sponsored |
| Locations | 1 site (Worthing) |
| Trial ID | NCT04123431 on ClinicalTrials.gov |
What this trial studies
This observational 10-year post-market surveillance follows adults who receive the CE‑marked ACE Acetabular Cup as part of an elective primary total hip replacement. Data are collected at intervals using patient-reported outcome questionnaires, review of X‑rays, and recording of complications and revisions. The device includes an H‑A.C. coating to promote bone integration and offers ceramic, polymer, or dual‑mobility liners to match surgeon preference. Patients must be able to consent and receive the approved implant combination, and exclusions include trauma cases, pregnancy, or inability to comply with follow-up.
Who should consider this trial
Good fit: Adults (18+) undergoing elective primary total hip replacement who can give informed consent and will receive the approved ACE Acetabular Cup with a JRI femoral stem and head.
Not a fit: Patients treated for hip fracture/trauma, those who cannot consent or comply with follow‑up, pregnant patients, or those receiving non‑approved implant combinations are not eligible and would not benefit from this surveillance.
Why it matters
Potential benefit: If successful, the study could confirm long‑term safety and function of the ACE cup and help surgeons and patients choose the best implant.
How similar studies have performed: Previous post‑market registries and studies of coated acetabular cups and dual‑mobility liners generally report good fixation and low revision rates, but device‑specific long‑term data remain important.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Worthing
- University Hospitals Sussex NHS Foundation Trust — Worthing, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.