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®.

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).

Study Overview

• Status: Completed
• Conditions: Unicompartmental Knee Arthroplasty
• Intervention / Treatment: Device: Primary Unicompartmental Knee Arthroplasty

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• Germany
  • Brakel, Germany, 33034
    • St. Vincenz Hospital Brakel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Univation® X	Device: Primary Unicompartmental Knee Arthroplasty; Primary implantation of an unicompartmental knee implant
iUni®	Device: Primary Unicompartmental Knee Arthroplasty; Primary implantation of an unicompartmental knee implant

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AAG-O-H-1641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No