Univation® X Follow-Up Study
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Details and patient eligibility
About
The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design.
The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients who underwent UKA in 2015/2016 (using one of the products under investigation)
- Signed informed consent
Exclusion criteria
- pregnancy
- patients < 18 years
Trial design
77 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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