Longterm-Evaluation of Vitelene® Against Standard (VITAS)

Aesculap

Status: Active, not recruiting

Conditions: Osteoarthritis, Hip; Arthritis

Treatments: Device: Vitelene; Device: XLPE

Study type: Observational

Funder types: Industry

Identifiers

NCT01713062

AAG-G-H-1113

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

400 participants in 2 patient groups

Vitelene

Description:

Plasmacup DC® with Vitelene® inlay manufactured by UHMWPE-XE (Ultra High Molecular Weight Polyethylene highly cross-linked with 0.1% Vitamin E) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)

Treatment:

Device: Vitelene

XLPE

Description:

Plasmacup DC® with a standard polyethylene inlay manufactured by UHMWPE-X (Ultra High Molecular Weight Polyethylene highly cross-linked) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)

Treatment:

Device: XLPE