A Register Based Prospective Study During Implementation of a New Cup
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total hip arthroplasty, Total hip arthroplasty.
- Who it may be relevant to
- Registry conditions: Prospective. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
STEISURE - Trident II - A Registerbased Multicentric Prospective Study
Overview
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
- Device Total hip arthroplasty
Total hip arthroplasty with a Trident II hemispherical cup - Device Total hip arthroplasty
Total hip arthroplasty with a Trident II Tritanium cup
Primary outcome measures
- Implant survival at 3 years [Time frame: 3 years]
Secondary outcome measures (8)
- Implant migration measured with Computer Tomography Microanalysis in a subcohort of patients motion Analysis (CTMA) 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 [Time frame: 10 years]
- EQ-5D [Time frame: 10 years]
- Plain radiographs in a sub-cohort of patients [Time frame: 10 years]
- Adverse events using the national patient register [Time frame: 10 years]
- Adverse events using the regional VEGA database [Time frame: 10 years]
- Oxford Hip Score [Time frame: 10 years]
- Forgotten Joint Score [Time frame: 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Department of Orthopaedics — Mölndal
Identifiers
NCT: NCT04350255 · STEISURE - Trident II