Evaluating the performance of U-Knee/Uni-Kroma knee implants
Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants
This study is collecting information from patients with U-Knee and Uni-Kroma knee implants to see how well these devices work after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Societe dEtude, de Recherche et de Fabrication Industry-sponsored |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT05876143 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect clinical data on the U-Knee and Uni-Kroma unicondylar knee prostheses following their market release. It focuses on assessing the short- and medium-term performance of these implants in patients who have undergone unicompartmental knee arthroplasty. The study will gather information from patients using these specific prostheses to evaluate their effectiveness and outcomes over time.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have received a U-Knee or Uni-Kroma unicompartmental knee prosthesis and are part of the social security affiliation scheme.
Not a fit: Patients who have objections to participating or those unable to follow postoperative instructions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of U-Knee/Uni-Kroma implants, potentially improving patient outcomes in knee arthroplasty.
How similar studies have performed: While this study is focused on specific implants, similar observational studies have shown success in evaluating knee prostheses, indicating a potential for valuable findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme. Exclusion Criteria: * Patients who objected to participating in the study and the processing of their data * Patients unable to understand the surgeon's instructions to complete their questionnaires or perform postoperative follow-up * Patients who already have a unicompartmental prosthesis on the knee in question that need to be revised.
Where this trial is running
Pierre-Bénite
- CHU Lyon Sud — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Clinical Department
- Email: clinical@serf.fr
- Phone: 0472056010
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.