Actively Recruiting
STEISURE - Trident II - A Registerbased Multicentric Prospective Study
Led by Sahlgrenska University Hospital · Updated on 2022-10-04
500
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
Sponsors
S
Sahlgrenska University Hospital
Lead Sponsor
S
Stryker Nordic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective study to evaluate the survival and clinical outcomes of hip implants, specifically the Trident II cup, in patients undergoing total hip replacement. The study aims to follow a group of at least 500 patients from several high-volume centers in Sweden to assess implant performance and patient health over time. The focus is on comparing two types of non-cemented Trident II acetabular cups and determining if there is any evidence of inferiority according to orthopedic benchmarking standards. Participants will receive total hip arthroplasty using either the Trident II Hemispherical cup or the Trident II Tritanium cup. Clinical data such as the EQ-5D, Oxford Hip Score, and Forgotten Joint Score will be collected before surgery and at 1, 3, 6, and 10 years afterwards. Imaging assessments including conventional X-rays will be performed before surgery, immediately after, and at 3, 6, and 10 years post-operation. Additionally, a subgroup of patients will undergo detailed implant migration analysis using Computer Tomography Microanalysis (CTMA) at postoperative, 3 months, 6 months, and 2 years. Throughout the study, participants will undergo regular evaluations involving clinical questionnaires, X-rays, and CT scans for those in the sub-cohort. The main outcome measured is implant survival at 3 years, with additional monitoring extending to 10 years for survival, quality of life scores, radiographic findings, and adverse events from national and regional patient registries. The total participation period can last up to 10 years, with multiple follow-up visits planned to closely monitor implant performance and patient well-being.
CONDITIONS
Brief Title
A Register Based Prospective Study During Implementation of a New Cup
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Difficulties to understand written information due to language problems or other reasons
- Use of augments needed
- Acute hip fracture
- Tumor in the hip joint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo total hip arthroplasty with either a Trident II Hemispherical or Tritanium acetabular cup.
1 surgery visit (in-person)
Duration - 10 years
Participants are followed after surgery with clinical assessments and imaging.
Visits at 1, 3, 6 months, 1, 2, 3, 6, and 10 years with clinical evaluations, radiographs, and CT scans in sub-cohorts
Trial Site Locations
Total: 1 location
1
Department of Orthopaedics
Mölndal, Västra Götaland County, Sweden, S-43180
Actively Recruiting
Research Team
M
Maziar Mohaddes, MD, PhD
A
Adam Rosenbaum, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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