A Prospective UK Multi-Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Disease
- Sponsor
- JRI Orthopaedics
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- Oxford Hip Score
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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 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.
Outcomes
Primary Outcomes
Oxford Hip Score
Time Frame: 3 years post-op
A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best)
Secondary Outcomes
- Radiological Assessment(1 year, 5 years and 10 years post-op)
- Oxford Hip Score(6 months, 1 year, 5 years, 7 years and 10 years post-op)
- EQ-5D-5L(6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op)
- Modified Harris Hip Score(6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op)
- Implant Survivorship(6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op)