A Register Based Prospective Study During Implementation of a New Cup

Study Overview
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Brief Summary
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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
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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.

Official Title
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STEISURE - Trident II - A Registerbased Multicentric Prospective Study

Conditions
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Prospective

Intervention / Treatment
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* Device: Total hip arthroplasty
* Device: Total hip arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trident II Hemispherical cup (Stryker Orthopaedics)<br>Total hip arthroplasty using non cemented Trident II Hemispherical acetabular cup | Device: Total hip arthroplasty<br>* Total hip arthroplasty with a Trident II hemispherical cup<br>Device: Total hip arthroplasty<br>* Total hip arthroplasty with a Trident II Tritanium cup<br>|
| Active Comparator: Trident II Tritanium cup (Stryker Orthopaedics)<br>Total hip arthroplasty using non cemented Trident II Tritanium acetabular cup | Device: Total hip arthroplasty<br>* Total hip arthroplasty with a Trident II hemispherical cup<br>Device: Total hip arthroplasty<br>* Total hip arthroplasty with a Trident II Tritanium cup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival at 3 years | Kaplan Meier survival data, cup revision and risk of revision used as endpoints | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Implant survival at 10 years | Kaplan Meier survival data, cup revision and risk of revision used as endpoints | 10 years | 
| EQ-5D | Patient-reported generic health outcome measure | 10 years | 
| Plain radiographs in a sub-cohort of patients | Using plain radiographs to evaluate signs of loosening and implant position | 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 | 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 | 10 years | 
| Oxford Hip Score | Patient-reported hip specific outcome measure | 10 years | 
| Forgotten Joint Score | Patient-reported hip specific outcome measure | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip arthroplasty, Implant survival, Clinical outcome, X-ray, Implant Migration, Patient reported outcomes