ACE UK PMCF Study
Research type
Research Study
Full title
A Prospective Multi-Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System
IRAS ID
249886
Contact name
Nirav Shah
Contact email
Sponsor organisation
JRI Orthopaedics Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 0 months, 0 days
Research summary
A total hip replacement (THR) 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. Some surgeries do fail. In more active patients it can fail due to the new hip becoming loose. Special coatings have been developed (such as hydroxyapatite-ceramic (H-A.C.)) that help improve the bond between the new hip and existing bone, resulting in the new hip lasting longer. JRI Orthopaedics have developed the ACE Acetabular system, which is CE marked. The ACE system has the H-A.C. coating on the acetabular component (the hip socket). But 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). The surgeon then choses one of JRI Orthopaedics femoral stem (the ball part of the hip). To ensure maximum safety and performance of medical devices surveillance of the device should be carried out over the devices lifetime. Therefore this study is a 10 year surveillance study to assess the clinical, functional and radiological outcomes of the CE-marked ACE Acetabular System. This is done by examining patient outcomes through questionnaires, reviews of X-rays and complications by patients who have received a THR using the ACE System at participating sites.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0415
Date of REC Opinion
2 Mar 2020
REC opinion
Further Information Favourable Opinion