Evaluating outcomes of the Persona knee system in knee replacement surgery
A Multicenter Prospective Cohort Study on Persona Total Knee System
This study is testing how well the Persona knee system works for knee replacement surgery by looking at complications and recovery in 700 patients over 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 4 sites (Copenhagen and 3 other locations) |
| Trial ID | NCT03495232 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate intra-operative and postoperative complications, long-term survivorship, and patient-reported outcome measures (PROMs) following primary total knee replacement using the Persona Total Knee system. The study will recruit 700 participants across several centers in the Nordic region, with follow-up visits planned for up to 10 years. Participants will undergo standard pain treatment and rehabilitation post-surgery, and data will be collected in accordance with local laws and regulations.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with clinical and radiological osteoarthritis of the knee who are scheduled to receive a primary unilateral total knee replacement.
Not a fit: Patients who are unwilling or unable to give consent or who have contraindications listed in the Instruction for Use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the Persona knee system, potentially improving outcomes for patients undergoing knee replacement surgery.
How similar studies have performed: Other studies evaluating similar knee arthroplasty systems have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement Exclusion Criteria: * Patients who are unwilling or unable to give consent, or to comply with the follow-up program. * Patients that meet any contraindications listed in the Instruction for Use
Where this trial is running
Copenhagen and 3 other locations
- Copenhagen University Hospital, Hvidovre — Copenhagen, Denmark (Recruiting)
- Institute Locomoteur de L'Ouest — Saint-Grégoire, France (Terminated)
- St Olavs Hospital — Trondheim, Norway (Completed)
- Ortopedic Clinic, Motala Specialist Care Capio AB — Motala, Sweden (Completed)
Study contacts
- Principal investigator: Anders Troelsen, Prof — Copenhagen University Hospital, Hvidovre
- Study coordinator: Chiara Griffoni
- Email: chiara.griffoni@zimmerbiomet.com
- Phone: +41795601628
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.