NCT03201172

Univation® X Follow-Up Study

Prospective Observational 2 Year Follow-up on a Retrospective Cohort of Primary Unicompartmental Knee Arthroplasty (UKA) Patients Treated With Univation® X or iUni®.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 77 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Unicompartmental Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Primary Unicompartmental Knee Arthroplasty	Primary implantation of an unicompartmental knee implant

Timeline

• Start date: 2017-09-25
• Primary completion: 2019-09-30
• Completion: 2020-04-01
• First posted: 2017-06-28
• Last updated: 2021-04-15

Locations

1 site across 1 country: Germany