Longterm-Evaluation of Vitelene® Against Standard

Arthritis Clinical Trial

— VITAS  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01713062
• Other study ID #: AAG-G-H-1113
• Status: Active, not recruiting
• Start date: January 2012
• Est. completion date: April 2030

Study information

• Verified date: April 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 2030
• Est. primary completion date: April 24, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis, Hip

Intervention

Device:
• Vitelene
THA
• XLPE
THA

Locations

Country	Name	City	State
Germany	Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef	Bendorf
Germany	Klinik für Orthopädie und Unfallchirurgie	Bochum
Germany	Klinikum Dortmund gGmbH - Orthopädische Klinik	Dortmund
Germany	Orthopädische Universitätsklinik Essen	Essen
Germany	Klinik und Poliklinik für Orthopädie	Halle
Germany	Orthopädische Klinik der MHH im Annastift	Hannover
Germany	Elisabeth Klinikum Olsberg	Olsberg

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision	The Oxidation index is measured after explantation in case of loosening of the inlay	Oxidation index is assessed in case of loosening and revision within 15 years
Secondary	Manifest radiological osteolyses		Measured radiologically after 1, 5, 10 and 15 years
Secondary	Traceable wear of polyethylene over 0.5 mm		Measured radiologically after 1, 5, 10 and 15 years
Secondary	Clinical Outcome	Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA)	After 1, 5, 10 and 15 years