Do TKA Implant Designs Affect Muscle Mass Change and Muscle Activity During Activities of Daily Living as Well as the Patient Immunological Response
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change from baseline knee extension moment at 6 and 12 months during gait
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participants receiving a knee implant must requiring a total knee replacement
排除标准
- •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
结局指标
主要结局
Change from baseline knee extension moment at 6 and 12 months during gait
时间窗: Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
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.
Change from baseline muscle quality assessed via MRI at 12 months
时间窗: Baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls
Proton density fat fraction of the quadriceps and hamstrings muscles will be measured via MRI
Change from baseline quadriceps muscle activation at 6 and 12 months during gait
时间窗: Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
Peak muscle activation of the quadriceps muscle will be measured with electromyography while the participant walks at their normal walking speed
次要结局
- Change in trace metal concentrations from baseline, 12 months, and 24 months(Baseline (within 1 month of surgery), 12 months post-surgery, 24 months post-surgery; and versus healthy controls)