ACE Acetabular Cup UK Multi-centre PMCF Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective UK Multi-Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System

Conditions
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Hip Disease

Intervention / Treatment
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* Device: Total Hip Replacement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACE Acetabular Cup System with XLPE Liner<br> | Device: Total Hip Replacement<br>* Primary elective total hip replacement<br>|
| ACE Acetabular Cup System with Ceramic Liner<br> | Device: Total Hip Replacement<br>* Primary elective total hip replacement<br>|
| ACE Acetabular Cup System with Dual Mobility Insert<br> | Device: Total Hip Replacement<br>* Primary elective total hip replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip Score | A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best) | 3 years post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survivorship | Implant survivorship based on revision rate and determined using the Kaplan-Meier analysis method | 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op | 
| Oxford Hip Score | A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best) | 6 months, 1 year, 5 years, 7 years and 10 years post-op | 
| Modified Harris Hip Score | A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 100 (best) | 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op | 
| EQ-5D-5L | A patient completed functional score to assess quality of life of the patient. Score range: -0.594 (worse) to 1.0 (best). | 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op | 
| Radiological Assessment | Radiographs reviewed for signs of radiolucencies, osteolysis, sclerosis and atrophy around the device | 1 year, 5 years and 10 years post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Replacement, Patient reported outcome measures, Post Market Clinical Follow-up / Post Market Surveillance