Ortho Development Corporation
To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.
The purpose of this study is to provide clinical evidence for the safety and effectiveness of Ortho Development® Corporation's Entrada™ Hip System (Figure 1). The Entrada™ Hip System was fully introduced to the US market in July, 2018. The Entrada™ Hip System includes the Entrada™ Hip Stem, an FDA approved (510(K) # K171249) femoral stem coupled with either a cobalt chrome or Biolox® Delta Ceramic femoral head. Additionally, the stem and head are coupled with either the Escalade® or Legend® acetabular shell, both of which utilize highly cross-linked polyethylene liners.
Inclusion Criteria: 1\. Scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip 2. System due to at least one of the following indications: * Osteoarthritis * Inflammatory arthropathy (Rheumatoid Arthritis, Psoriatic Arthritis, etc.) with sufficient bone stock for standard primary THA implants * Avascular Necrosis with sufficient bone stock for standard primary THA implants * Post-traumatic Arthritis * Secondary arthritis due to congenital hip dysplasia 3. Willing and able to provide written informed consent for participation in the study. 4\. Aged 18 - 80 years. 5. Abl…
To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.
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