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.
Study Type
OBSERVATIONAL
Enrollment
225
Primary elective total hip replacement
University Hospitals Sussex NHS Foundation Trust
Worthing, United Kingdom
RECRUITINGOxford 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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