Overview

This trial is active, not recruiting.

Conditions osteoarthritis, hip, arthritis
Treatments vitelene, xlpe
Phase phase 4
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

Male or female 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 February 2016.
Information provided to ClinicalTrials.gov by Aesculap AG.