Overview

This trial is active, not recruiting.

Conditions osteoarthritis, hip, arthritis
Treatments vitelene, xlpe
Sponsor Aesculap AG
Start date January 2012
End date April 2015
Trial size 400 participants
Trial identifier NCT01713062, AAG-G-H-1113

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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®)
vitelene
THA
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®)
xlpe
THA

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Manifest radiological osteolyses
time frame: Measured radiologically after 1, 5, 10 and 15 years
Traceable wear of polyethylene over 0.5 mm
time frame: Measured radiologically after 1, 5, 10 and 15 years
Clinical Outcome
time frame: After 1, 5, 10 and 15 years

Eligibility Criteria

All participants from 18 years up to 75 years old.

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

Additional Information

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)
Principal investigator Marcus Jäger, Univ.-Prof. Dr. med
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Aesculap AG.