Longterm-Evaluation of Vitelene® Against Standard (VITAS)

This study is currently recruiting participants.

Verified May 2013 by Aesculap AG

Sponsor:

Information provided by (Responsible Party):

Aesculap AG

ClinicalTrials.gov Identifier:

NCT01713062

First received: October 15, 2012

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2012

Last Updated Date

May 13, 2013

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision [ Time Frame: Oxidation index is assessed in case of loosening and revision within 15 years ] [ Designated as safety issue: No ]

The Oxidation index is measured after explantation in case of loosening of the inlay

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01713062 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Manifest radiological osteolyses [ Time Frame: Measured radiologically after 1, 5, 10 and 15 years ] [ Designated as safety issue: No ]
Traceable wear of polyethylene over 0.5 mm [ Time Frame: Measured radiologically after 1, 5, 10 and 15 years ] [ Designated as safety issue: No ]
Clinical Outcome [ Time Frame: After 1, 5, 10 and 15 years ] [ Designated as safety issue: No ]
Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Longterm-Evaluation of Vitelene® Against Standard

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

adult patients

Condition ^ICMJE

Osteoarthritis, Hip
Arthritis

Intervention ^ICMJE

Device: Vitelene
THA
Device: XLPE
THA

Study Group/Cohort (s)

Vitelene
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®)

Intervention: Device: Vitelene
XLPE
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®)

Intervention: Device: XLPE

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

December 2029

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Robert Weber	+49-7461-95-2605	robert.weber@aesculap.de
Contact: Andrea Weiler, Dr.	+49-7461-95-2721	andrea.weiler@aesculap.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01713062

Other Study ID Numbers ^ICMJE

AAG-G-H-1113

Has Data Monitoring Committee

Responsible Party

Aesculap AG

Study Sponsor ^ICMJE

Aesculap AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marcus Jäger, Univ.-Prof. Dr. med

Universitätsklinikum Essen

Information Provided By

Aesculap AG

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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