A Prospective Multi-center Study on Total Hip Arthroplasty With E1

Status Terminated

Clinical Trial Summary

The primary objectives of this clinical study include:

- Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1

- Compare E1 wear used with CoCr and Biolox Delta heads

Clinical Trial Description

This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement.

Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases.

Randomization will occur via random number generator by 4 blocks randomization. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01883492
Study type	Interventional
Source	Zimmer Biomet
Contact
Status	Terminated
Phase	N/A
Start date	March 11, 2013
Completion date	March 15, 2019

View Details

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