This study compares two total knee replacement implants to asses muscle function and quality, and the immune response to the implants. 30 patients will receive the Smith and Nephew Journey II implant, while 30 patients will receive the Zimmer NexGen LPS-flex implant. 15 healthy controls will also be recruited and compared.
Patients will undergo biomechanics testing while they complete sit-to-stand, stand-to-sit, lateral step down, level walking, and single leg balance tasks up to 1 month before surgery, and 6 and 12 months after surgery. They will also undergo MRI imaging up to 1 month before surgery and 12 months after surgery to assess muscle quality. A secondary outcome will also be to analyze the immunological response in the patients who received femoral components made of oxidized zirconium versus contemporary components made of cobalt chrome. Fifteen healthy controls will also participate in the study and will undergo the biomechanical, MRI and blood draws at a single visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
Patients will be randomly assigned to 1 of 2 devices
Patients will be randomly assigned to 1 of 2 devices
The Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGChange from baseline knee extension moment at 6 and 12 months during gait
Peak knee extension moment will be measured by combining three-dimensional images of movement with time, the knee extension will be calculated in degrees while the participant walks at their normal walking speed.
Time frame: Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
Change from baseline muscle quality assessed via MRI at 12 months
Proton density fat fraction of the quadriceps and hamstrings muscles will be measured via MRI
Time frame: Baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls
Change from baseline quadriceps muscle activation at 6 and 12 months during gait
Peak muscle activation of the quadriceps muscle will be measured with electromyography while the participant walks at their normal walking speed
Time frame: Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
Change in trace metal concentrations from baseline, 12 months, and 24 months
Peripheral blood will be collected prior to surgery and at 12 months post-surgery; for symptomatic patients, a third blood draw will occur at 24 months post-surgery. Concentrations of cobalt, chromium, and Nickle will be measured by inductively coupled plasma-mass spectrometry.
Time frame: Baseline (within 1 month of surgery), 12 months post-surgery, 24 months post-surgery; and versus healthy controls
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