Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty

Status Completed

Clinical Trial Summary

This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.

Clinical Trial Description

The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System. A total of 200 patients will be enrolled in this study that will last 12 years (2 year enrollment plus 10 years follow-up) with the following visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03672916
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Completed
Phase
Start date	May 2011
Completion date	April 2023

View Details

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