ACE Acetabular Cup UK Multi-centre PMCF Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ACE Acetabular Cup System with XLPE Liner
|
Device: Total Hip Replacement
Primary elective total hip replacement
|
| ACE Acetabular Cup System with Ceramic Liner
|
Device: Total Hip Replacement
Primary elective total hip replacement
|
| ACE Acetabular Cup System with Dual Mobility Insert
|
Device: Total Hip Replacement
Primary elective total hip replacement
|
Outcome Measures
Primary Outcome Measures
- Oxford Hip Score [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 Outcome Measures
- Implant Survivorship [6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op]
Implant survivorship based on revision rate and determined using the Kaplan-Meier analysis method
- Oxford Hip Score [6 months, 1 year, 5 years, 7 years and 10 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)
- Modified Harris Hip Score [6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op]
A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 100 (best)
- EQ-5D-5L [6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op]
A patient completed functional score to assess quality of life of the patient. Score range: -0.594 (worse) to 1.0 (best).
- Radiological Assessment [1 year, 5 years and 10 years post-op]
Radiographs reviewed for signs of radiolucencies, osteolysis, sclerosis and atrophy around the device
Other Outcome Measures
- Adverse Device Effects [6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op]
Trends and anaylsis or adverse device effects reported
Eligibility Criteria
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 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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- JRI Orthopaedics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JRI-CS-010