NCT06657248 Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
| NCT ID | NCT06657248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aesculap AG |
| Condition | Gonarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-02 |
| Primary Completion | 2027-10 |
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 150 participants in total. It began in 2026-04-02 with a primary completion date of 2027-10.
⚠ 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
The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany.
Eligibility Criteria
Inclusion Criteria: * Indication for a primary medial unicompartmental knee endoprosthesis Acc. to Instructions for Use: * Both cruciate ligaments intact * Lateral ligaments intact * Leg axis amenable to passive correction * Varus deformity under 15° * Bending capability of at least 90° * Extension deficit no greater than 5-10° * Written informed consent of patient * Kellgran \& Lawrence Score \> II (only straight or varus * Patients with moderate radiological symptoms * Patients without clinical symptoms Exclusion Criteria: * Pregnancy * Patient age \<18 and \> 75 years * BMI ≥ 40 * High risk patients ASA \> III
Contact & Investigator
Rolf Haaker, Prof. Dr.
PRINCIPAL INVESTIGATOR
St. Vincenz Hospital Brakel
Frequently Asked Questions
Who can join the NCT06657248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gonarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06657248 currently recruiting?
Yes, NCT06657248 is actively recruiting participants. Contact the research team at info@aesculap.de for enrollment information.
Where is the NCT06657248 trial being conducted?
This trial is being conducted at Potsdam, Germany, Bünde, Germany, Brakel, Germany, München, Germany.
Who is sponsoring the NCT06657248 clinical trial?
NCT06657248 is sponsored by Aesculap AG. The principal investigator is Rolf Haaker, Prof. Dr. at St. Vincenz Hospital Brakel. The trial plans to enroll 150 participants.