MedTrace Logo

ACE Acetabular Cup Spanish PMCF Study

NCT07115732 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-08-29

No results posted yet for this study

Summary

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.

Conditions

  • Hip Disease

Interventions

DEVICE

Total Hip Replacement

Primary elective total hip replacement

Sponsors & Collaborators

  • JRI Orthopaedics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2030-08-31
Completion
2036-07-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115732 on ClinicalTrials.gov