NCT03551678Unknown不适用
Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
VA Palo Alto Health Care System2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年6月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Knee Adduction Moment
研究概览
简要总结
The purpose of this study is to determine changes to knee joint loading, biological markers, and cartilage structure following a novel active feedback gait retraining program in anterior cruciate ligament reconstructed patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-40 years
- •history of primary ACLR with or without meniscal repair
- •full weight-bearing status
- •neutral to varus knee alignment
- •plans to remain in the area for at least 8 months.
排除标准
- •Kellgren-Lawrence (KL) radiographic grade > 2
- •additional injury or surgery to the involved knee
- •BMI >30 kg/m2
- •use of walking, orthopedic, or prosthetic assistive device
- •pregnancy
- •inability to have MRI
结局指标
主要结局
Knee Adduction Moment
时间窗: Change from baseline to immediately after 8 weeks of retraining
Knee Joint Loading (%Bw\*Ht) will be assessed at baseline and immediately after gait retraining
次要结局
- Medial knee compartment qMRI(Change from baseline to 6 months after retraining)
- Serum inflammatory markers(Change from baseline to immediately after 8 weeks of retraining)
- Knee Adduction Moment(Change from baseline to 6 months after retraining)
研究者
Constance Chu, MD
Study Principal Investigator
VA Palo Alto Health Care System
研究点 (2)
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