A Register Based Prospective Study During Implementation of a New Cup
STEISURE - Trident II - A Registerbased Multicentric Prospective Study
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
ExpectedOctober 4, 2022
October 1, 2022
4.3 years
April 8, 2020
October 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implant survival at 3 years
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
3 years
Secondary Outcomes (8)
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
Implant survival at 10 years
10 years
EQ-5D
10 years
Plain radiographs in a sub-cohort of patients
10 years
Adverse events using the national patient register
10 years
- +3 more secondary outcomes
Study Arms (2)
Trident II Hemispherical cup (Stryker Orthopaedics)
ACTIVE COMPARATORTotal hip arthroplasty using non cemented Trident II Hemispherical acetabular cup
Trident II Tritanium cup (Stryker Orthopaedics)
ACTIVE COMPARATORTotal hip arthroplasty using non cemented Trident II Tritanium acetabular cup
Interventions
Total hip arthroplasty with a Trident II hemispherical cup
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Difficulties to understand written information due to language problems or other reasons
- Use of augments needed
- Acute hip fracture
- Tumor in the hip joint
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sahlgrenska University Hospitallead
- Stryker Nordiccollaborator
Study Sites (1)
Department of Orthopaedics
Mölndal, Västra Götaland County, S-43180, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sahlgrenska University Hospital, Sweden
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 17, 2020
Study Start
August 1, 2020
Primary Completion
December 1, 2024
Study Completion (Estimated)
August 1, 2030
Last Updated
October 4, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
Due to regulations associated with national registers in Sweden alla data will be presented on an aggregated level, individual patient data will not be shared.