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| Name | Class |
|---|---|
| University of Ottawa | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant Groups | Experimental | Group will receive the Smith & Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant |
|
| Healthy Control Group | No Intervention | Control group that will not be undergoing a total knee arthroplasty |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer NexGen LPS-Flex | Device | Patients will be randomly assigned to 1 of 2 devices |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | 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 | 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 | Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (within 1 month of surgery), 12 months post-surgery, 24 months post-surgery; and versus healthy controls |
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Inclusion Criteria:
Exclusion Criteria:
Healthy Controls Inclusion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wade Gofton, MD FRCSC | Contact | 6137985555 | 18779 | wgofton@toh.ca |
| Meaghan Dufresne | Contact | 613-737-8899 | meadufresne@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mario Lamontagne, PhD | University of Ottawa | Principal Investigator |
| Isabelle Catelas, PhD, PEng | University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Smith & Nephew Journey II |
| Device |
Patients will be randomly assigned to 1 of 2 devices |
|
| D012216 |
| Rheumatic Diseases |