Evaluating a new hip implant's performance
STEISURE - Trident II - A Registerbased Multicentric Prospective Study
NA · Sahlgrenska University Hospital · NCT04350255
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital (other) |
| Locations | 1 site (Mölndal, Västra Götaland County) |
| Trial ID | NCT04350255 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals requiring primary hip replacement and eligible for uncemented fixation of the acetabular component.
Not a fit: Patients with acute hip fractures, tumors in the hip joint, or those requiring augments will not benefit from this study.
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 performed: Other studies have successfully evaluated hip implants using similar methodologies, indicating a precedent for this approach.
Eligibility criteria
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 this trial is running
Mölndal, Västra Götaland County
- Department of Orthopaedics — Mölndal, Västra Götaland County, Sweden (RECRUITING)
Study contacts
- Study coordinator: Maziar Mohaddes, MD, PhD
- Email: maziar.mohaddes@gmail.com
- Phone: +46730701147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prospective, Hip arthroplasty, Implant survival, Clinical outcome, X-ray, Implant Migration, Patient reported outcomes