Evaluating a new hip implant's performance
Official title: STEISURE - Trident II - A Registerbased Multicentric Prospective Study
Run by Sahlgrenska University Hospital · NCT04350255 · Data updated 2026-11-12
This study is testing how well a new hip implant works for people getting hip replacement surgery by tracking their recovery and implant performance over 10 years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 75 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 1 site (Mölndal, Västra Götaland County) |
| Status | Recruiting |
| Started | August 1, 2020 |
| Main results expected | December 1, 2024 |
| Study ends | August 1, 2030 |
| Registry record updated | October 4, 2022 |
| Trial ID | NCT04350255 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals requiring primary hip replacement and eligible for uncemented fixation of the acetabular component.
✕Probably not a fit
Patients with acute hip fractures, tumors in the hip joint, or those requiring augments will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study follows a cohort of at least 500 patients undergoing total hip arthroplasty with the Trident II cup to assess implant survival and clinical outcomes. Data will be collected from multiple high-volume centers in Sweden, focusing on clinical parameters and radiographic findings over a period of 10 years. Patients will be evaluated using standardized scores and imaging techniques at various time points to ensure comprehensive monitoring of the implant's performance. The study aims to benchmark these outcomes against established recommendations to determine the implant's effectiveness.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and longevity of hip implants for patients undergoing hip replacement surgery.
How similar studies have gone: Other studies have successfully evaluated hip implants using similar methodologies, indicating a precedent for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Department of Orthopaedics
Mölndal, Västra Götaland County, Sweden Recruiting
Study contacts
- Study coordinator: Maziar Mohaddes, MD, PhD
- Email: maziar.mohaddes@gmail.com
- Phone: +46730701147
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.