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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04105179
• Other study ID #: 20180532
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Ottawa Hospital Research Institute
• Contact: Wade Gofton, MD FRCSC
• Phone: 6137985555
• Email: wgofton[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Inflammation Knees
• Osteoarthritis, Knee

Intervention

Device:
• Zimmer NexGen LPS-Flex
Patients will be randomly assigned to 1 of 2 devices
• Smith & Nephew Journey II
Patients will be randomly assigned to 1 of 2 devices

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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