Prospective
Conditions
Keywords
Hip arthroplasty, Implant survival, Clinical outcome, X-ray, Implant Migration, Patient reported outcomes
Brief summary
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.
Detailed description
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.
Interventions
DEVICETotal hip arthroplasty
Total hip arthroplasty with a Trident II hemispherical cup
Sponsors
Stryker Nordic
Sahlgrenska University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Primary hip replacement * Eligible for uncemented fixation of the acetabular component * Suitable for one of the stem designs from Stryker Orthopaedics * Accepts follow-up according to the study protocol
Exclusion criteria
* Difficulties to understand written information due to language problems or other reasons * Use of augments needed * Acute hip fracture * Tumor in the hip joint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival at 3 years | 3 years | Kaplan Meier survival data, cup revision and risk of revision used as endpoints |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival at 10 years | 10 years | Kaplan Meier survival data, cup revision and risk of revision used as endpoints |
| EQ-5D | 10 years | Patient-reported generic health outcome measure |
| Plain radiographs in a sub-cohort of patients | 10 years | Using plain radiographs to evaluate signs of loosening and implant position |
| Implant migration measured with Computer Tomography Microanalysis in a subcohort of patients motion Analysis (CTMA) in a sub-cohort of patients | CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement | Using Computer Tomography Micro-motion Analysis (CTMA) to measure implant migration in a sub-cohort of patients |
| Adverse events using the regional VEGA database | 10 years | 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 |
| Oxford Hip Score | 10 years | Patient-reported hip specific outcome measure |
| Forgotten Joint Score | 10 years | Patient-reported hip specific outcome measure |
| Adverse events using the national patient register | 10 years | 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 |
Countries
Sweden
Contacts
Primary ContactMaziar Mohaddes, MD, PhD
Backup ContactAdam Rosenbaum, MD
Outcome results
None listed