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Mini Stem Radiostereometric Analysis Study — MISRSA  

Osteoarthritis, Hip Clinical Trial

Official title:
A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip System by Radiostereometric Analysis

Clinical Trial Summary

The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations.

Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.

Clinical Trial Description

The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01064531
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Completed
Phase
Start date June 30, 2009
Completion date April 22, 2016
View Details
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