STEISURE - Trident II - A Registerbased Multicentric Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Implant survival at 3 years
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Implant survival at 3 years
Time Frame: 3 years
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
Secondary Outcomes
- EQ-5D(10 years)
- Adverse events using the regional VEGA database(10 years)
- 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)
- Plain radiographs in a sub-cohort of patients(10 years)
- Implant survival at 10 years(10 years)
- Adverse events using the national patient register(10 years)
- Oxford Hip Score(10 years)
- Forgotten Joint Score(10 years)
Investigators
Maziar Mohaddes Ardebili
Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden