ACE Acetabular Cup Spanish PMCF Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total Hip Replacement.
- Who it may be relevant to
- Registry conditions: Hip Disease. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Single Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System in Spain
Overview
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, involving the replacement of both the hip ball and socket. Its goal is to provide pain relief and enable the patient to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has an H-A.C. coating to promote osseointegration of the device within the host bone. To increase the surgeon's choice and thus suitability for the patient, there is the option of three 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 device's 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 will be done by examining patient outcomes through questionnaires, reviews of X-rays, and recording any complications in patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.
Interventions
- Device Total Hip Replacement
Primary elective total hip replacement
Primary outcome measures
- Oxford Hip Score [Time frame: 3 years post-op]
Secondary outcome measures (5)
- Implant Survivorship [Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op]
- Oxford Hip Score [Time frame: 6 months, 1 year, 5 years, 7 years and 10 years post-op]
- Modified Harris Hip Score [Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op]
- EQ-5D-5L [Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op]
- Radiological Assessment [Time frame: 1 year, 5 years and 10 years post-op]
Eligibility criteria
Inclusion criteria
- Patients deemed suitable for elective primary THR, as per indications in the IFU.
- Male or female, 18 years to 85 years.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital General de Granollers — Barcelona
Identifiers
NCT: NCT07115732 · JRI-CS-011