Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty (VIKEP)

February 25, 2026 updated by: Aesculap AG

Prospective, Randomized, Single-blind, Multinational, Long-term Study for the Evaluation of the Clinical Outcome, Oxidation Profile and Wear Analysis of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty

Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

605

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie
    • Isere
      • Échirolles, Isere, France, 38130
        • Hôpital Sud - CHU de Grenoble
  • Germany
      • Berlin, Germany, 13086
        • Park-Klinik Weißensee
      • Eisenberg, Germany, 07607
        • Waldkliniken Eisenberg
      • Reinbek, Germany, 21465
        • Krankenhaus Reinbek, St. Adolf Stift
      • Rostock, Germany, 18057
        • Universitätsklinikum Rostock, Klinik für Orthopädie
    • North Rhine-Westphalia
      • Bünde, North Rhine-Westphalia, Germany, 32257
        • Lukas Krankenhaus
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56073
        • Brüderhaus Koblenz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

multicentric

Description

Inclusion Criteria:

  • Indication for a total knee replacement with a mobile-bearing UC or PS inlay
  • Written informed consent for participating at the clinical study
  • Willingness and mental ability to participate at the long-term follow-up examinations

Exclusion Criteria:

  • Patient age < 18 and > 80 years
  • Pregnancy
  • High risk patients (ASA class >3)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
With Vitamin E
Device: UHMWPE with Vitamin E
e.motion Pro (PS and UC) with MXE gliding surface
Without Vitamin E
Device: UHMWPE without Vitamin E
e.motion Pro (PS and UC) with β-PE gliding surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome measured with the KSS [performance]
Time Frame: 10 years postoperatively
The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA. It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.
10 years postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: until the last follow-up at 10 years postoperatively
Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. The revision-free survival rate is the performance indicator of the product under investigation and confirms the clinical outcome of the knee prosthesis. Information on survival of the implant will be collected until the last follow-up of the study patients took place.
until the last follow-up at 10 years postoperatively
Progress of Clinical Outcome [Oxford Score] compared to baseline
Time Frame: Preoperatively, 3 months, 12 months, 3 years, 5 years, 7 years, 10 years
The Oxford Knee Score is a reliable 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing total knee replacement. It is short, reproducible, valid and sensitive to clinically important changes over time. Each of the 12 questions on the OKS is scored in the same way with the score decreasing as the reported symptoms increase (i.e. become worse). All questions are laid out with response categories denoting least (or no) symptoms to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0), as detailed for question 1 below. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome, (to convert from the 60-12 system to the 0-48 system and vice versa subtract the score from 60).
Preoperatively, 3 months, 12 months, 3 years, 5 years, 7 years, 10 years
Quality of Life [EQ-5D-5L]
Time Frame: Preoperatively, 3 months, 12 months, 5 years, 10 years
EQ-5D is a standardized 5-dimension 5-level measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine".
Preoperatively, 3 months, 12 months, 5 years, 10 years
Comparison of Radiographic evaluation over time
Time Frame: baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Imaging will be used to evaluate the implant status as well as device condition and potential presence of device-related Adverse Events including fracture, wear, loosening or radiolucencies.
baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Comparison of Radiographic alignment over time
Time Frame: baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Alignment (femoral-knee baseline angle, tibial-knee baseline angle, femoral-tibial angle (mechanical))
baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Oxidation profile and wear analysis of available retrievals
Time Frame: During the course of the study up to 10 years postoperatively
Available retrievals of explanted investigational products will be analysed by the biomechanical laboratory of the sponsor. Therefore any retrieval has to be returned to the Sponsor's facility after its revision in order to perform these analyses. Special focus of theses analyses are the oxidation profile, the wear behaviour, the mechanics and the cumulative linear abrasion of these retrievals. These measurements can further analyse the in-vivo performance of the device of the reference and investigational product
During the course of the study up to 10 years postoperatively
Further analysis of patients having a revision of the primary implant
Time Frame: During the course of the study up to 10 years postoperatively
In case a patient requires the revision of the primary implanted knee prosthesis, additional information on the revision surgery shall be collected. The reason for revision together with the clinical symptoms shall be documented. Further examinations (e.g. arthroscopy) prior to the revision and the date of revision surgery is to be documented. If pre revision radiographs are taken as part of the clinical routine, the results of the radiographic analysis shall be documented in the respective CRF.
During the course of the study up to 10 years postoperatively
(Serious) Adverse Events
Time Frame: During the course of the study up to 10 years postoperatively
During the course of the study, any upcoming intra- or postoperative (serious) adverse device events or effects related or not related to the product under investigation, will be documented. The total number of AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product.
During the course of the study up to 10 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

Raylytic GmbH
B. Braun Medical France

Investigators

  • Principal Investigator: Wolfram Mittelmeier, Prof. Dr., Orthopädische Uniklinik Rostock, Direktor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

October 1, 2034

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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