Clinical trial NCT01713062: Longterm-Evaluation of Vitelene® Against Standard
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Hip
Arthritis
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2012-10-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients

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.


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

Primary outcomes:
measure: Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision
timeFrame: Oxidation index is assessed in case of loosening and revision within 15 years
Secondary outcomes:
measure: Manifest radiological osteolyses
timeFrame: Measured radiologically after 1, 5, 10 and 15 years
measure: Traceable wear of polyethylene over 0.5 mm
timeFrame: Measured radiologically after 1, 5, 10 and 15 years
measure: Clinical Outcome
timeFrame: After 1, 5, 10 and 15 years
Other outcomes:
Locations:
city: Bendorf
country: Germany
facility: Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef
city: Bochum
country: Germany
facility: Klinik für Orthopädie und Unfallchirurgie
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH - Orthopädische Klinik
city: Essen
country: Germany
facility: Orthopädische Universitätsklinik Essen
city: Halle
country: Germany
facility: Klinik und Poliklinik für Orthopädie
city: Hannover
country: Germany
facility: Orthopädische Klinik der MHH im Annastift
city: Olsberg
country: Germany
facility: Elisabeth Klinikum Olsberg
Study officials:
affiliation: Universitätsklinikum Essen
name: Marcus Jäger, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References: