Osteoarthritis, KneeArthritis, RheumatoidIntra-Articular FracturesJoint InstabilityGenu Valgum or Varum
Investigational drug(s) / intervention(s)
UHMWPE with Vitamin EUHMWPE without Vitamin E
UHMWPE with Vitamin E: e.motion Pro (PS and UC) with MXE gliding surface
UHMWPE without Vitamin E: e.motion Pro (PS and UC) with β-PE gliding surface
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Clinical Outcome measured with the KSS [performance] — 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.
Trial sites (8)
Facility
City
Region
Status
Hôpital Sud - CHU de Grenoble
Échirolles
Isere
CHU Amiens-Picardie
Amiens
France
Lukas Krankenhaus
Bünde
North Rhine-Westphalia
Brüderhaus Koblenz
Koblenz
Rhineland-Palatinate
Park-Klinik Weißensee
Berlin
Germany
Waldkliniken Eisenberg
Eisenberg
Germany
Krankenhaus Reinbek, St. Adolf Stift
Reinbek
Germany
Universitätsklinikum Rostock, Klinik für Orthopädie
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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