NCT07115732

ACE Acetabular Cup Spanish PMCF Study

A Prospective Single Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System in Spain

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: JRI Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Total Hip Replacement	Primary elective total hip replacement

Timeline

• Start date: 2025-08-01
• Primary completion: 2030-08-01
• Completion: 2036-07-01
• First posted: 2025-08-11
• Last updated: 2025-08-29

Locations

1 site across 1 country: Spain