KCT0009409尚未招募Unknown
Comparison of joint kinematics of knee osteotomy, flatfoot, chronic lateral ankle instability, and normal subjects using mobile dual X-ray system (Single-Center, Sponsor Initiated Exploratory Trial)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •Patients with medial compartment osteoarthritis accompanied by varus deformity of the knee joint requiring high tibial osteotomy
- •1) Aged 19 to less than 70 years.
- •2) Patients with Kellgren-Lawrence grade 1 or above medial compartment osteoarthritis on plain radiographs and a varus deformity of the knee joint of 5 degrees or more.
- •3) Patients without a history of surgery other than arthroscopy of the knee joint.
- •4) Patients willing and able to follow the procedures outlined in this clinical trial plan.
- •5) Patients with no plans for pregnancy during the clinical trial period and willing to consent to contraception if they are fertile women.
- •6) Patients who voluntarily consent in writing to participate in this clinical trial.
- •Patients with flatfoot disorder
- •1) Aged 19 to less than 70 years.
- •2) Patients diagnosed with flatfoot disorder based on clinical symptoms and radiographic measurements.
- •Flatfoot diagnosis criteria include:
- •- Clinical symptoms: Pain on the lateral and medial aspects of the midfoot during activity.
- •- Imaging: Angle between the talus and first metatarsal greater than 5 degrees on weight-bearing lateral foot radiographs and hindfoot valgus angle greater than 5 degrees on lateral hindfoot radiographs.
- •3) Patients willing and able to follow the procedures outlined in this clinical trial plan.
- •4) Patients with no plans for pregnancy during the clinical trial period and willing to consent to contraception if they are fertile women.
- •5) Patients who voluntarily consent in writing to participate in this clinical trial.
- •Patients with chronic lateral ankle instability
- •1) Aged 19 to less than 70 years.
- •2) Patients diagnosed with chronic lateral ankle instability based on anterior drawer and varus stress tests and stress radiographs.
- •3) Patients without a history of ankle joint surgery other than lateral ankle ligament repair.
- •4) Patients willing and able to follow the procedures outlined in this clinical trial plan.
- •5) Patients with no plans for pregnancy during the clinical trial period and willing to consent to contraception if they are fertile women.
- •6) Patients who voluntarily consent in writing to participate in this clinical trial.
- •Healthy control group without foot disorders
- •1) Aged 19 to less than 70 years.
- •2) Patients without instability, locking, or catching sensations in the feet and no history of foot surgery.
- •3) Patients willing and able to follow the procedures outlined in this clinical trial plan.
- •4) Patients with no plans for pregnancy during the clinical trial period and willing to consent to contraception if they are fertile women.
- •5) Patients who voluntarily consent in writing to participate in this clinical trial.
排除标准
- •Patients with medial compartment osteoarthritis accompanied by varus deformity of the knee joint requiring high tibial osteotomy
- •1) Patients with chronic inflammatory arthritis such as rheumatoid arthritis.
- •2) Patients with knee flexion contracture of 15 degrees or more and a flexion range of motion less than 90 degrees, indicating impaired joint mobility.
- •3) Patients with medial compartment osteoarthritis of the knee joint.
- •4) Patients with open growth plates.
- •5) Patients with a BMI over 35 or a weight of 135kg or more.
- •6) Pregnant or lactating women.
- •7) Other patients deemed ineligible for participation in the clinical trial by the investigator, including those with cardiac-related issues, seizures, individuals with metal or electronic devices implanted in the head, individuals with unexplained pain, and recipients of cardiac pacemakers, among others, as outlined in the product's precautions and contraindications.
- •Patients with flatfoot disorder, Patients with chronic lateral ankle instability, Healthy control group without foot disorders
- •1) Patients with instability in both feet.
- •2) Patients with generalized ligament laxity.
- •3) Patients who have undergone previous surgery for chronic lateral ankle instability and require reoperation, or other individuals with foot surgical history deemed unsuitable for participation in the study by the principal investigator.
- •4) Patients with open growth plates.
- •5) Patients with a BMI over 35 or a weight of 135kg or more.
- •6) Pregnant or lactating women.
- •7) Other patients deemed ineligible for participation in the clinical trial by the investigator, including those with cardiac-related issues, seizures, individuals with metal or electronic devices implanted in the head, individuals with unexplained pain, and recipients of cardiac pacemakers, among others, as outlined in the product's precautions and contraindications.
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