Univation® X Follow-Up Study | NCT03201172

Studies
Univation® X Follow-Up Study

NCT03201172

Sponsor

Aesculap AG

Status

Completed

Last Update Posted

Apr 15, 2021Actual

Enrollment

77Actual

Phase

Not provided

Conditions

Unicompartmental Knee Arthroplasty

Interventions

Primary Unicompartmental Knee Arthroplasty

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2017Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Apr 1, 2020Actual

First Submitted Date

May 23, 2017

First Submission Date that Met QC Criteria

Jun 27, 2017

First Posted Date

Jun 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2021

Last Update Posted Date

Apr 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Univation® X			Device: Primary Unicompartmental Knee Arthroplasty
iUni®			Device: Primary Unicompartmental Knee Arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Primary Unicompartmental Knee Arthroplasty	Device	Primary implantation of an unicompartmental knee implant	Univation® X iUni®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
KOOS	Knee Injury and Osteoarthritis Outcome Score	2 years after primary implantation
axis justice position	radiological analysis

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Vincenz Hospital Brakel		Brakel		33034	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40866508	Derived	Haaker R, Moussa A, Sabev D. No advantage for patient-specific UKA in comparison with standard UKA regarding clinical and functional results at short-term follow-up. Eur J Orthop Surg Traumatol. 2025 Aug 27;35(1):362. doi: 10.1007/s00590-025-04467-2.