NCT00962013

Restoration® Modular Revision Hip System Post Market Study

A Prospective Open-Label Evaluation of the Restoration® Modular System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DEVICE	Restoration® Modular Revision Hip System	Restoration® Modular Revision System

Timeline

• Start date: 2004-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-08-19
• Last updated: 2017-03-29
• Results posted: 2014-08-15

Locations

13 sites across 1 country: United States