NCT01469299已完成不适用
Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 8
- 主要终点
- Joint Balance
研究概览
简要总结
The primary objectives of this evaluation are: 1) To attempt to refine the current clinical understanding of "balance" 2) To determine if patients with quantifiably balanced knee joints exhibit improved clinical outcomes versus patient with residual imbalance, as measured by the VERASENSE™ Knee System
Secondary objectives:
- Determine whether a difference in inter-compartment loads and soft tissue tension exists between the physicians intra-operative feel compared to the quantifiable data measured by the VERASENSE™ Knee System
- Determine which ligament releases are performed by the surgeon to improve soft tissue balance while utilizing the information from the VERASENSE™ Knee System
- Evaluate range of motion, pain, physical function, activity level, and patient satisfaction between baseline (pre-operative) and post-operative follow-up as well as radiographic success and survivorship of the knee implants
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be a candidate for a primary total knee replacement
- •Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis post-traumatic arthritis
- •Subject's joint must be anatomically and functionally suited to receive the selected implant
- •Subject is 50 years of age or older (≥ 50 yrs) at the time of consent
- •Subject is likely to be available for all study visits
- •Subject is able and willing to sign the informed consent and follow study procedures
- •Subject is not pregnant
排除标准
- •Prior total knee arthroplasty
- •Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- •Subject is pregnant
- •Subject has an active infection or joint sepsis
- •Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints)
- •Ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- •Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
结局指标
主要结局
Joint Balance
时间窗: At time of Total Knee Surgery
次要结局
- Patient Reported Outcome Measures(Changes from Baseline at 3-years)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and NewbornEarly Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)Erythroblastosis, FetalNCT03755128Janssen Research & Development, LLC17
已完成
不适用
Clinical Evaluation and Assessment of Instruments and Biomarkers in Subjects With Wilson DiseaseWilson DiseaseNCT04531189Ultragenyx Pharmaceutical Inc16
进行中（未招募）
不适用
Clinical Utility for Ion Endoluminal SystemLung DiseasesPulmonary NoduleLung CancerNCT03893539Intuitive Surgical365
已完成
不适用
Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its TreatmentHemophilia ANCT02396862Bayer272
已完成
不适用
A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in aHUS Patients in South KoreaaHUSNCT05405777Handok Inc.97