ACE Acetabular Cup Spanish PMCF Study

JRI Orthopaedics

Status: Not yet enrolling

Conditions: Hip Disease

Treatments: Device: Total Hip Replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT07115732

JRI-CS-011

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

ACE Acetabular Cup System with XLPE Liner

Treatment:

Device: Total Hip Replacement

ACE Acetabular Cup System with Ceramic Liner

Treatment:

Device: Total Hip Replacement