A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Status Completed

Clinical Trial Summary

The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene

Clinical Trial Description

Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected.

This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable.

The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00698152
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Completed
Phase
Start date	January 23, 2006
Completion date	January 15, 2016

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