In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Osteoarthritis / Knee Replacement
Title
Version D-A Prospective, Multi-Center, Surgeon Assessment of Intraoperative Fit of the Signature Personalized Patient Care System For Use with the Oxford Knee (Orthopedics / Knee Replacement)
Description
The purpose of this study is to evaluate the fit of the Signature System instruments during your surgery.
Most knee instruments are made of metal and come in different sizes to fit the bones of patients of all sizes. The Signature Patient Care System guides are customized, meaning they are meant to fit just one patient. This is done by taking an MRI (Magnetic Resonance Imaging) and using the information from the MRI to make the Signature System instruments.
IRB Number
Pro1709
Inclusion/Notes
INCLUSION:
Patients who are willing and able to have an MRI scan performed of the affected leg 4-6
weeks prior to their scheduled procedure.
Patients who have signed the IRB approved Informed Consent Form.
Patients eligible to receive the Oxford Partial Knee Arthroplasty System per the approved
patient labeling.
EXCLUSION:
Patients who have not signed the IRB approved Informed Consent Form.
Patients unwilling or unable to have MRI 4-6 weeks prior to scheduled procedure.
Patients not eligible to receive the Oxford Partial Knee Arthroplasty System per the approved
patient labeling.
