NCT04105179

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

Do TKA Implant Designs Affect Muscle Mass Change and Muscle Activity During Activities of Daily Living as Well as the Patient Immunological Response

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Osteoarthritis, Knee
• Inflammation Knees

Interventions

Type	Name	Description
DEVICE	Zimmer NexGen LPS-Flex	Patients will be randomly assigned to 1 of 2 devices
DEVICE	Smith & Nephew Journey II	Patients will be randomly assigned to 1 of 2 devices

Timeline

• Start date: 2019-04-29
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-09-26
• Last updated: 2022-08-08

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study