ACE Acetabular Cup UK Multi-centre PMCF Study

JRI Orthopaedics

Status

Not yet enrolling

Conditions

Hip Disease

Treatments

Device: Total Hip Replacement

Study type

Observational

Funder types

Industry

Identifiers

NCT04123431

JRI-CS-010

Details and patient eligibility

About

A total hip replacement 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. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has a H-A.C. coating to promote ossoeintegration of the device within the host bone. 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).

To ensure maximum safety and performance of medical devices surveillance of the device should be carried out over the devices 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 is done by examining patient outcomes through questionnaires, reviews of X-rays and complications by patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.

Enrollment

225 estimated patients

Sex

All

Ages

18+ 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 or older.

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 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.