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

Active Not RecruitingN/A

Sponsor: Aesculap AG

Conditions: Osteoarthritis, Knee, Arthritis, Rheumatoid, Intra-Articular Fractures, Joint Instability, Genu Valgum or Varum

Interventions: UHMWPE with Vitamin E, UHMWPE without Vitamin E

Countries: France, Germany

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Locations (8)

Échirolles, Isere, France
Amiens, France
Bünde, North Rhine-Westphalia, Germany
Koblenz, Rhineland-Palatinate, Germany
Berlin, Germany
Eisenberg, Germany
Reinbek, Germany
Rostock, Germany