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NCT03201172

Univation® X Follow-Up Study

Completed Last updated 15 April 2021
What this trial tests

trial testing Primary Unicompartmental Knee Arthroplasty in Unicompartmental Knee Arthroplasty in 77 participants. Completed in 1 April 2020.

Timeline
25 September 2017
Primary endpoint
30 September 2019
1 April 2020

Quick facts

Lead sponsorAesculap AG
StatusCompleted
Study typeOBSERVATIONAL
Enrollment77
Start date25 September 2017
Primary completion30 September 2019
Estimated completion1 April 2020
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Aesculap AG — full company profile →

Who can join

18 and older, any sex, with Unicompartmental Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. No advantage for patient-specific UKA in comparison with standard UKA regarding clinical and functional results at short-term follow-up.
    Haaker R, Moussa A, Sabev D. · · 2025 · cited 1× · PMID 40866508 · DOI 10.1007/s00590-025-04467-2

Verify or expand the search:

Other recruiting trials for Unicompartmental Knee Arthroplasty

Currently open trials in the same condition.

Other Aesculap AG trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03201172.

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