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Univation® X Follow-Up Study

NCT03201172 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2021-04-15

No results posted yet for this study

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

DEVICE

Primary Unicompartmental Knee Arthroplasty

Primary implantation of an unicompartmental knee implant

Sponsors & Collaborators

  • Aesculap AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2019-09-30
Completion
2020-04-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201172 on ClinicalTrials.gov