Longterm-Evaluation of Vitelene® Against Standard

Randomised Prospective Multicenter Longterm-Evaluation of the Survival Rate of the Implant, Wear and Periprosthetic Osteolysis of Highly Cross-linked Polyethylene With and Without Addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X)

The purpose of this randomised prospective multicenter longterm study is to evaluate the survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip Arthroplasty.

Inclusion:

• Minimum age: 18 years
• Maximum age: 75 years
• Indication of cementless THA
• Approval of study participation and treatment according to study protocol
• Physical and mental willingness of adhering to clinical and radiological follow up

Exclusion:

• Patient is not able to join follow up
• Increased risk of anaesthesia according to the "American Society of Anesthesiology": ASA IV
• Tumor disease
• Alcohol and drug dependency
• Permanent cortisone therapy
• Clinical relevant infections
• Pregnancy and planned pregnancy
• Previous interventions like adjustment-osteotomy, treatment of fractures or THA on affected side
• Acute fractures of the affected hip joint
• Patients with bone quality, which doesn´t allow a cementless treatment
• Requirements of clinical relevant deformities (condition after preoperation or bone fracture, leg length discrepancy > 30 mm, Offset-reduction about > 30 mm)
• Small acetabular treatments with 28 mm heads
• Treatments without using ceramic heads
• Treatments which require neck prolonging components