MicroPort Orthopedics Inc.
Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.
Inclusion Criteria: 1\. Has previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including acetabular shells, acetabular liners and femoral heads. 2\. Has previously undergone or currently has been determined to undergo a primary THA for any of the following: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; * inflammatory…
Single study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads.
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Actual pay is set by the research site.
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