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Clinical Trial Summary

The purpose of this study is to meet a PMA condition of approval of the BHR System. The study will evaluate the long term safety and effectiveness of the BHR system in patients with non-inflammatory and inflammatory arthritis.


Clinical Trial Description

This is a post-approval, prospective, non-randomized, longitudinal, unmasked, multi-center, clinical trial designed to evaluate the longer-term safety and effectiveness of the BHR system. The data collected will permit clinical evaluation for the device performance in improving hip pain, function and range of motion through ten years. The study will permit radiographic evaluation of proper component fixation and alignment maintenance through 10 years post-operative. The incidence of revision is an especially important measure in this study. Data collected will allow analysis of the implant survivorship. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00611585
Study type Interventional
Source Smith & Nephew, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date September 2006
Completion date December 2026

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