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

Aesculap

Status: Active, not recruiting

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

Treatments: Device: UHMWPE without Vitamin E; Device: UHMWPE with Vitamin E

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04618016

AAG-O-H-1906

Details and patient eligibility

About

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

Enrollment: 605 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

605 participants in 2 patient groups

With Vitamin E

Treatment:

Device: UHMWPE with Vitamin E

Without Vitamin E

Treatment:

Device: UHMWPE without Vitamin E