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Restoration® Modular Revision Hip System Post Market Study

2014-08-27 03:19:56 | BioPortfolio

Summary

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

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 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

Conditions

Arthroplasty, Replacement, Hip

Intervention

Restoration Modular Revision Hip System

Location

Orthopaedic Specialty Institute
Orange
California
United States
92868

Status

Active, not recruiting

Source

Stryker Orthopaedics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:56-0400

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Medical and Biotech [MESH] Definitions

Partial or total replacement of a joint.

Replacement of the hip joint.

Partial or total replacement of one or more FINGERS, or a FINGER JOINT.

Replacement of the SHOULDER JOINT.

Replacement of the ELBOW JOINT.

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