Restoration® Modular Revision Hip System Post Market Study

Status Completed

Clinical Trial Summary

The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

Clinical Trial Description

The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Arthroplasty, Replacement, Hip

Clinical Trial Details

NCT number	NCT00962013
Study type	Interventional
Source	Stryker Orthopaedics
Contact
Status	Completed
Phase	N/A
Start date	January 2004
Completion date	December 2011

View Details

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