In a prospective register-based study, we aim to evaluate the implant survival, clinical outcomes and X-ray findings by following a cohort of patients operated with the Trident II cup.
Data will be collected from a cohort consisting of minimum 500 total hip arthroplasties. The patients will be recruited from multiple high volume centers in Sweden. To determine if there is evidence of inferiority as per benchmarking recommendations by The Orthopaedic Data Evaluation Panel the following parameters will be studied: Clinical parameters such as EQ-5D, Oxford Hip Score and Forgotten Joint Score, preoperative and after 1, 3, 6 and 10 years. Conventional radiography will be done preoperatively, postoperatively, 3, 6 and 10 years after total hip replacement. CTMA will be done postoperatively, 3 and 6 month and 2 years after total hip replacement.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Total hip arthroplasty with a Trident II hemispherical cup
Total hip arthroplasty with a Trident II Tritanium cup
Department of Orthopaedics
Mölndal, Västra Götaland County, Sweden
RECRUITINGImplant survival at 3 years
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
Time frame: 3 years
Implant migration measured with Computer Tomography Microanalysis in a subcohort of patients motion Analysis (CTMA) in a sub-cohort of patients
Using Computer Tomography Micro-motion Analysis (CTMA) to measure implant migration in a sub-cohort of patients
Time frame: CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement
Implant survival at 10 years
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
Time frame: 10 years
EQ-5D
Patient-reported generic health outcome measure
Time frame: 10 years
Plain radiographs in a sub-cohort of patients
Using plain radiographs to evaluate signs of loosening and implant position
Time frame: 10 years
Adverse events using the national patient register
ICD codes för surgical and medical adverse events following primary total hip arthroplasty, as defined by the National Board of Health and Welfare will be merged with data in the SHAR (The Swedish Hip Arthroplasty Register). This database includes mainly secondary care visits
Time frame: 10 years
Adverse events using the regional VEGA database
ICD (International Classification of Diseases) codes för surgical and medical adverse events following primary total hip arthroplasty, as defined by the National Board of Health and Welfare will be merged with data in the SHAR (The Swedish Hip Arthroplasty Register). This regional database includes all contacts (both within primary and secondary care) for patients living in the region of Western Sweden
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 10 years
Oxford Hip Score
Patient-reported hip specific outcome measure
Time frame: 10 years
Forgotten Joint Score
Patient-reported hip specific outcome measure
Time frame: 10 years