Department of Orthopaedics
Mölndal, Västra Götaland County, S-43180, Sweden
Location status: Recruiting
Recruiting
NCT Number: NCT04350255
A Register Based Prospective Study During Implementation of a New Cup
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
30 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Total hip arthroplasty
DeviceTotal hip arthroplasty with a Trident II hemispherical cup
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
-
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
Using Computer Tomography Micro-motion Analysis (CTMA) to measure implant migration in a sub-cohort of patients
-
Implant survival at 10 years
Time frame: 10 years
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
-
EQ-5D
Time frame: 10 years
Patient-reported generic health outcome measure
-
Plain radiographs in a sub-cohort of patients
Time frame: 10 years
Using plain radiographs to evaluate signs of loosening and implant position
-
Adverse events using the national patient register
Time frame: 10 years
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
-
Adverse events using the regional VEGA database
Time frame: 10 years
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
-
Oxford Hip Score
Time frame: 10 years
Patient-reported hip specific outcome measure
-
Forgotten Joint Score
Time frame: 10 years
Patient-reported hip specific outcome measure
Study contacts
Contact information is provided by the study sponsor or research team.
Adam Rosenbaum, MD
CONTACT
Maziar Mohaddes, MD, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Sahlgrenska University Hospital
Other
Collaborators
- Stryker Nordic
Registry information
Official study title
STEISURE - Trident II - A Registerbased Multicentric Prospective Study
Important dates
- Study start
- 2020
- Primary completion
- 2024
- Study completion
- 2030
- First posted
- Apr 17, 2020
- Registry last updated
- Oct 4, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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