How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response

  • STATUS
    Recruiting
  • End date
    Dec 19, 2023
  • participants needed
    75
  • sponsor
    Ottawa Hospital Research Institute
Updated on 4 October 2022
Investigator
Wade Gofton, MD FRCSC
Primary Contact
The Ottawa Hospital (5.8 mi away) Contact
total knee replacement
Accepts healthy volunteers

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, while 30 patients will receive the Zimmer NexGen LPS-flex implant. 15 healthy controls will also be recruited and compared.

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 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.

Details
Condition Osteoarthritis, Knee, Inflammation Knees
Treatment Zimmer NexGen LPS-Flex, Smith & Nephew Journey II
Clinical Study IdentifierNCT04105179
SponsorOttawa Hospital Research Institute
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The participants receiving a knee implant must requiring a total knee replacement

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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