NCT05876143 Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants
| NCT ID | NCT05876143 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Societe dEtude, de Recherche et de Fabrication |
| Condition | Unicompartmental Knee Arthroplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2030-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-01-01 with a primary completion date of 2030-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage).The main objective of this study is to collect short- and medium-term clinical data on the unicondylar knee prosthesis U-Knee / Uni-Kroma, in order to evaluate the performance of these implants.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05876143 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unicompartmental Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05876143 currently recruiting?
Yes, NCT05876143 is actively recruiting participants. Contact the research team at clinical@serf.fr for enrollment information.
Where is the NCT05876143 trial being conducted?
This trial is being conducted at Pierre-Bénite, France.
Who is sponsoring the NCT05876143 clinical trial?
NCT05876143 is sponsored by Societe dEtude, de Recherche et de Fabrication. The trial plans to enroll 400 participants.