Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Smith & Nephew, Inc.
The primary purpose of this study is to demonstrate the REDAPT™ Revision Femoral System modular stem cumulative revision rate at 5 years. The secondary purpose of this study is to provide 10 years of safety and performance data on the REDAPT™ Revision Femoral System modular stem in terms of Standard of Care Radiographic Assessment, Harris Hip Sore (if obtained prior to implant), adverse event assessment, whole blood metal ion level assessment for Cobalt and Chromium (only performed if subject if symptomatic with pain, swelling, and/or functional limitation related to the device and/ implant procedure as assessed by the Principal Investigator (PI), and Metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) or Computed Tomography (CT) will be obtained if metal ion levels of Cobalt and/or Chromium \> 7parts per billion (ppb) 140 subjects have been enrolled in the study at 5 clinical study sites around the world. A Clinical Study Report (CSR) will be completed at years 5 and 10.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
