Evaluating the performance of U-Knee/Uni-Kroma knee implants
Official title: Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants
Run by Societe dEtude, de Recherche et de Fabrication · NCT05876143 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Societe dEtude, de Recherche et de Fabrication Industry-sponsored |
| Locations | 1 site (Pierre-Bénite) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | January 31, 2030 |
| Study ends | January 31, 2035 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT05876143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who have objections to participating or those unable to follow postoperative instructions 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 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.
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 gone: While this study is focused on specific implants, similar observational studies have shown success in evaluating knee prostheses, indicating a potential for valuable findings.
Who can join: the full rules
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 it's running
-
CHU Lyon Sud
Pierre-Bénite, France Recruiting
Study contacts
- Study coordinator: Clinical Department
- Email: clinical@serf.fr
- Phone: 0472056010
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Post-op prednisone vs standard steroid regimen after knee or hip replacement
This study tests a 5-day oral prednisone course after knee or hip replacement to see if pain, swelling, and glucose control are better or different than the usual intraoperative steroid approach.
-
Early cognitive changes after same-day hip or knee replacement
This study tests whether older adults (65 or older, 70 per description) who have same-day discharge after hip or knee replacement show changes in cognitive test performance from before surgery to the first day after surgery.
-
XPEO-E liner with SERF dual-mobility hip cups for total hip replacement
This project will test how well the XPEO-E hip liner performs and is tolerated in adults receiving a SERF total hip replacement.
-
Follow-up on the Madison Total Knee Prosthesis for knee pain relief
This study is testing how well the MADISON Total Knee Prosthesis works for people with knee pain over 15 years to see if it helps them feel better and stay safe.
-
Long-term evaluation of hip prostheses performance
This study is trying to see how well certain hip implants work and how safe they are for adults getting these devices over a 15-year period.
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.