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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03201172

Enrollment

Registered

2017-06-28

Start date

2017-09-25

Completion date

2020-04-01

Last updated

2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unicompartmental Knee Arthroplasty

Brief 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).

Interventions

DEVICEPrimary Unicompartmental Knee Arthroplasty

Primary implantation of an unicompartmental knee implant

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy 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

Design outcomes

Primary

Measure	Time frame	Description
Knee joint function	2 years after primary implantation	Knee Society Score

Secondary

Measure	Time frame	Description
KOOS	2 years after primary implantation	Knee Injury and Osteoarthritis Outcome Score
axis justice position	preoperative and until discharge from hospital (within 1 week postoperatively)	radiological analysis
radiolucent lines	2 years after primary implantation	radiological analysis
tibial slope	2 years after primary implantation	radiological analysis

Other

Measure	Time frame	Description
Adverse Events	2 years after primary implantation	Number of Adverse Events during Follow-Up

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026