Arthritis, Osteoarthritis, Hip
Conditions
Brief summary
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.
Interventions
DEVICEVitelene
THA
DEVICEXLPE
THA
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision | Oxidation index is assessed in case of loosening and revision within 15 years | The Oxidation index is measured after explantation in case of loosening of the inlay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manifest radiological osteolyses | Measured radiologically after 1, 5, 10 and 15 years | — |
| Traceable wear of polyethylene over 0.5 mm | Measured radiologically after 1, 5, 10 and 15 years | — |
| Clinical Outcome | After 1, 5, 10 and 15 years | Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA) |
Countries
Germany
Outcome results
None listed