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

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Inflammation Knees; Osteoarthritis, Knee

Treatments: Device: Smith & Nephew Journey II; Device: Zimmer NexGen LPS-Flex

Study type: Interventional

Funder types: Other

Identifiers

NCT04105179

20180532

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Implant Groups

Experimental group

Description:

Group will receive the Smith \& Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant

Treatment:

Device: Zimmer NexGen LPS-Flex

Device: Smith & Nephew Journey II

Healthy Control Group

No Intervention group

Description:

Control group that will not be undergoing a total knee arthroplasty