AESCULAP® Plasmafit® Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene

Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

Status: Completed

Conditions: Rheumatic Arthritis; Osteoarthritis, Hip; Degenerative Osteoarthritis

Treatments: Device: Plasmafit® Vitelene® Vitamin E

Study type: Observational

Funder types: Other

Identifiers

NCT05291130

2020-3

Details and patient eligibility

About

Objectives of this study is evaluate effectivness of AESCULAP® Plasmafit® Plasmafit Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene compare to the sane sistem without Vitamin E, and ceramic or metal femoral heads

Full description

Osteoarthritis is one most common disease in aged population, that most advanced stage needs surgical treatment. Surgical treatment usually include installation of implants. Every year new types of implants were fabricated from the new material. The effectiveness of this new devices need carefully independent assess in clinic.

Enrollment: 400 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who needs total knee replacement surgery
• Informed consent from the patients.

Exclusion criteria

Trial design

400 participants in 3 patient groups

Plasmafit® Vitelene® Vitamin E ceramic femoral heads

Description:

Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and bioceramic femoral heads

Treatment:

Device: Plasmafit® Vitelene® Vitamin E

Plasmafit® Vitelene® Vitamin E metal femoral heads

Description:

Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and metal femoral heads

Treatment:

Device: Plasmafit® Vitelene® Vitamin E

Plasmafit® polyethylene metal femoral heads

Description:

Plasmafit® Acetabular Cup System with polyethylene and metal femoral heads