Clinical trial NCT04105179: How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Inflammation Knees
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Ottawa
First posted: 2019-09-26
Enrollment: 75
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline knee extension moment at 6 and 12 months during gait
timeFrame: Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
measure: Change from baseline muscle quality assessed via MRI at 12 months
timeFrame: Baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls
measure: Change from baseline quadriceps muscle activation at 6 and 12 months during gait
timeFrame: Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
Secondary outcomes:
measure: Change in trace metal concentrations from baseline, 12 months, and 24 months
timeFrame: Baseline (within 1 month of surgery), 12 months post-surgery, 24 months post-surgery; and versus healthy controls
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Mario Lamontagne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Isabelle Catelas, PhD, PEng
role: PRINCIPAL_INVESTIGATOR
References: