Univation® X Follow-Up Study

Completed

• Conditions: Unicompartmental Knee Arthroplasty
• Interventions: Device: Primary Unicompartmental Knee Arthroplasty

• Registration Number: NCT03201172
• Lead Sponsor: Aesculap AG

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 available

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Start: 2017-09-25
• Primary Completion: 2019-09-30
• Study Completion: 2020-04-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Univation® X	Primary Unicompartmental Knee Arthroplasty	-
iUni®	Primary Unicompartmental Knee Arthroplasty	-

Primary Outcome Measures

Name	Time	Method
Knee joint function	2 years after primary implantation	Knee Society Score

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Vincenz Hospital Brakel; 🇩🇪 Brakel, Germany