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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04350255
Other study ID # STEISURE - Trident II
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date August 1, 2030

Study information

Verified date October 2022
Source Sahlgrenska University Hospital, Sweden
Contact Maziar Mohaddes, MD, PhD
Phone +46730701147
Email maziar.mohaddes@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Total hip arthroplasty
Total hip arthroplasty with a Trident II hemispherical cup
Total hip arthroplasty
Total hip arthroplasty with a Trident II Tritanium cup

Locations

Country Name City State
Sweden Department of Orthopaedics Molndal Västra Götaland

Sponsors (2)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden Stryker Nordic

Country where clinical trial is conducted

Sweden, 

Outcome

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
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