Longterm-Evaluation of Vitelene® Against Standard - Full Text View

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Hip Arthritis	Device: Vitelene Device: XLPE	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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)

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Vitamin E

Drug Information available for: Polyethylene

U.S. FDA Resources

Further study details as provided by Aesculap AG:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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)

Estimated Enrollment:	400
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2029
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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®)	Device: Vitelene THA
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®)	Device: XLPE THA

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

adult patients

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713062

Contacts

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

Locations

Germany
Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef	Recruiting
Bendorf, Germany, 56170
Contact: Joern WP Michael, PD Dr. +49-2622-708-0
Principal Investigator: Joern WP Michael, PD Dr.
Klinik für Orthopädie und Unfallchirurgie	Recruiting
Bochum, Germany, 44791
Contact: Christoph von Schulze Pellengahr, Prof. Dr. +49-234-612-0
Principal Investigator: Christoph von Schulze Pellengahr, Prof. Dr.
Klinikum Dortmund gGmbH - Orthopädische Klinik	Withdrawn
Dortmund, Germany, 44137
Orthopädische Universitätsklinik Essen	Recruiting
Essen, Germany, 45147
Contact: Marcus Jäger, Prof. Dr. +49-201-7233181
Principal Investigator: Marcus Jäger, Prof. Dr.
Klinik und Poliklinik für Orthopädie	Recruiting
Halle, Germany, 06097
Contact: Karl-Stefan Delank, Prof. Dr. +49-345-5574-805 orthopaedie@uk-halle.de
Principal Investigator: Karl-Stefan Delank, Prof. Dr.
Orthopädische Klinik der MHH im Annastift	Recruiting
Hannover, Germany, 30625
Contact: Henning Windhagen, Prof. Dr. +49-511-5354-0
Principal Investigator: Henning Windhagen, Prof. Dr.
Elisabeth Klinikum Olsberg	Recruiting
Olsberg, Germany, 59939
Contact: Axel Wilke, Prof.Dr.Dr. +49-2962-803-0
Principal Investigator: Axel Wilke, Prof.Dr.Dr.

Sponsors and Collaborators

Aesculap AG

Investigators

Principal Investigator:

Marcus Jäger, Univ.-Prof. Dr. med

Universitätsklinikum Essen

More Information

No publications provided

Responsible Party:	Aesculap AG
ClinicalTrials.gov Identifier:	NCT01713062 History of Changes
Other Study ID Numbers:	AAG-G-H-1113
Study First Received:	October 15, 2012
Last Updated:	May 13, 2013
Health Authority:	Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:

Arthritis
Osteoarthritis
Osteoarthritis, Hip

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013

Longterm-Evaluation of Vitelene® Against Standard (VITAS)