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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Inflammation Knees
• Intervention / Treatment: Device: Zimmer NexGen LPS-Flex; Device: Smith & Nephew Journey II

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wade Gofton, MD FRCSC; Phone Number: 18779 6137985555; Email: wgofton@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implant Groups; Group will receive the Smith & Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant	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
No Intervention: Healthy Control Group; Control group that will not be undergoing a total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline knee extension moment at 6 and 12 months during gait	Peak knee extension moment will be measured by combining three-dimensional images of movement with time, the knee extension will be calculated in degrees while the participant walks at their normal walking speed.	Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
Change from baseline muscle quality assessed via MRI at 12 months	Proton density fat fraction of the quadriceps and hamstrings muscles will be measured via MRI	Baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls
Change from baseline quadriceps muscle activation at 6 and 12 months during gait	Peak muscle activation of the quadriceps muscle will be measured with electromyography while the participant walks at their normal walking speed	Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in trace metal concentrations from baseline, 12 months, and 24 months	Peripheral blood will be collected prior to surgery and at 12 months post-surgery; for symptomatic patients, a third blood draw will occur at 24 months post-surgery. Concentrations of cobalt, chromium, and Nickle will be measured by inductively coupled plasma-mass spectrometry.	Baseline (within 1 month of surgery), 12 months post-surgery, 24 months post-surgery; and versus healthy controls

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: University of Ottawa
• Investigators: Principal Investigator: Mario Lamontagne, PhD, University of Ottawa; Principal Investigator: Isabelle Catelas, PhD, PEng, University of Ottawa

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Inflammation; Osteoarthritis, Knee
• Other Study ID Numbers: 20180532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes