Prospective Clinical Trial
Official title:
STEISURE - Trident II - A Registerbased Multicentric Prospective Study
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | August 1, 2030 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Orthopaedics | Molndal | Västra Götaland |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden | Stryker Nordic |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implant survival at 3 years | Kaplan Meier survival data, cup revision and risk of revision used as endpoints | 3 years | |
Secondary | 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 | CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement | |
Secondary | Implant survival at 10 years | Kaplan Meier survival data, cup revision and risk of revision used as endpoints | 10 years | |
Secondary | EQ-5D | Patient-reported generic health outcome measure | 10 years | |
Secondary | Plain radiographs in a sub-cohort of patients | Using plain radiographs to evaluate signs of loosening and implant position | 10 years | |
Secondary | 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 | 10 years | |
Secondary | 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 | 10 years | |
Secondary | Oxford Hip Score | Patient-reported hip specific outcome measure | 10 years | |
Secondary | Forgotten Joint Score | Patient-reported hip specific outcome measure | 10 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01694108 -
Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.
|
Phase 4 | |
Completed |
NCT00520416 -
Prospective, Non-Randomized Evaluation of Carbon Dioxide Gas as a Contrast Agent in Comparison With Iodinated Contrast in Endovascular Aneurysm Repair
|
N/A | |
Recruiting |
NCT05145712 -
Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas
|
N/A | |
Recruiting |
NCT03728829 -
Targeted Next Generation Sequencing for the Efficacy of Trastuzumab Neoadjuvant Chemotherapy in Breast Cancer
|