Status:
UNKNOWN
How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
University of Ottawa
Conditions:
Osteoarthritis, Knee
Inflammation Knees
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
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,...
Detailed Description
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 mon...
Eligibility Criteria
Inclusion
- The participants receiving a knee implant must requiring a total knee replacement
Exclusion
- Any degenerative conditions (other than osteoarthritis at the affected knee) impacting joints of the lower extremities
- bilateral knee replacements
- previous joint replacement at the affected knee
- any other past or present conditions that may impact gait
- any active infection and any diagnosed conditions that may affect the local and systemic immune response (e.g., rheumatoid arthritis, HIV infection, lupus, pregnancy, and thrombocytosis)
- BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI \> 35 kg/m2 and a WC \> 102 cm in men or \> 88 cm in women will be excluded from the study.
- Healthy Controls Inclusion
- controls must not suffer from lower extremity injuries or joint conditions that might alter gait dynamics Exclusion
- BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI \> 35 kg/m2 and a WC \> 102 cm in men or \> 88 cm in women will be excluded from the study
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04105179
Start Date
April 29 2019
End Date
December 1 2023
Last Update
August 8 2022
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6