← Back to all trials
Active Not Recruiting
NCT01713062
Longterm-Evaluation of Vitelene® Against Standard
Conditions: Osteoarthritis, Hip, Arthritis
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 400
Sponsor: Aesculap AG
Location: Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef Bendorf
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT01713062). StuddyBuddy aggregates publicly available trial information.