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

Osteoarthritis, Knee Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Inflammation
• Inflammation Knees
• Osteoarthritis, Knee

• NCT number: NCT04105179
• Study type: Interventional
• Source: Ottawa Hospital Research Institute
• Contact: Wade Gofton, MD FRCSC
• Phone: 6137985555
• Email: wgofton@toh.ca
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2019
• Completion date: December 2023