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.
Study Type
OBSERVATIONAL
Enrollment
120
Primary elective total hip replacement
Hospital General de Granollers
Barcelona, Catalonia, Spain
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)
Time frame: 3 years post-op
Implant Survivorship
Implant survivorship based on revision rate and determined using the Kaplan-Meier analysis method
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 1 year, 5 years and 10 years post-op
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