Comparing two knee implant systems for patient satisfaction after surgery
A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.
This study is testing which of two knee implant systems, ORIGIN® or VANGUARD® PS, makes patients happier after knee surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Symbios Orthopedie SA Industry-sponsored |
| Locations | 1 site (Mainz) |
| Trial ID | NCT04728542 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate patient satisfaction following total knee arthroplasty using two different implant systems: the patient-matched ORIGIN® and the off-the-shelf VANGUARD® PS. It involves a prospective, comparative design with 140 subjects and includes a two-year follow-up to assess clinical and device performance outcomes. The study is conducted in a single center, focusing on real-world hospital practices and patient experiences.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals scheduled for total knee arthroplasty who meet the inclusion criteria.
Not a fit: Patients who are not undergoing knee arthroplasty or do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient satisfaction and outcomes in knee replacement surgeries.
How similar studies have performed: Other studies have shown success in comparing different knee implant systems, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion/exclusion criteria
Where this trial is running
Mainz
- University Medical Center of Johannes Gutenberg-University Mainz — Mainz, Germany (Recruiting)
Study contacts
- Principal investigator: Philippe Drees, Prof — Johannes Gutenberg University Mainz
- Study coordinator: Lukas Eckhard
- Email: lukas.eckhard@unimedizin-mainz.de
- Phone: +496131177302
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.