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Post Approval Study: NOVATION Ceramic Articulation Hip System

2014-07-23 21:21:50 | BioPortfolio

Summary

The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System ("NOVATION ™ Ceramic AHS"). Ten (10) years of follow-up data will be collected in this study. The first five (5) years of subject follow-up will involve clinical (Harris Hip Score, adverse events), radiographic, and self-assessment evaluation. The remaining five (5) years of subject follow-up will be accomplished with an outcomes questionnaire that will be completed by the subjects to evaluate the survivorship status of their hip replacement.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Total Hip Replacement (Non-inflammatory)

Intervention

Novation Ceramic

Location

Shrock Orthopedic Research
Fort Lauderdale
Florida
United States
33316

Status

Recruiting

Source

Exactech

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:21:50-0400

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