NCT02027974撤回不适用
ICONACY Hip Clinical Data Acquisition (13-1-M-239)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Harris Hip Score must be > or = 80 at 2 years
研究概览
简要总结
The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for total hip replacement surgery.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This must be a primary hip replacement on this hip
- •Patient is 30 years of age or older
- •Have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis
- •Patient is likely to be available for evaluation for the duration of the study
- •Able and willing to sign the informed consent and follow study procedures
排除标准
- •Is younger than 30 years of age
- •If there has been a total hip replacement on this hip in the past (no revisions allowed in study)
- •Infection, or history of infection, acute or chronic, local or systemic
- •Alcoholism or other addictions
- •Muscular, neurological or vascular deficiencies which compromise the affected extremity
- •Obesity(BMI>45)
- •Insufficient bone quality
- •Loss of ligamentous structures
- •High levels of physical activity
- •Materials sensitivity
- •Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
- •Patient is pregnant
- •Is not able to read English language
结局指标
主要结局
Harris Hip Score must be > or = 80 at 2 years
时间窗: 2 years
Radiographic success
时间窗: 2 years
Oxford Hip Score > 40 points at 2 years
时间窗: 2 years
次要结局
- Patient Satisfaction at 1, 2, and 3 years(1, 2, and 3 years)
- Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years(1, 2, and 3 years)
- Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years(1, 2, and 3 years)
研究者
相似试验
已完成
不适用
Clinical study- Revelation® Hip SystemJPRN-UMIN000006107Shonan Kamakura Joint Reconstruction Center100
终止
4 期
A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip ReplacementCollagen DisordersRheumatoid ArthritisOsteoarthritisPost-traumatic ArthritisTraumatic Femoral FracturesNonunion of Femoral FracturesCongenital Hip DysplasiaSlipped Capital Femoral EpiphysisAvascular NecrosisNCT00208390DePuy International275
Unknown
不适用
Multi-Site, Post-Market Study of the ICONACY I-Hip SystemDegenerative Joint DiseaseNCT02131389Iconacy Orthopedic Implants, LLC.500
终止
不适用
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone CementOsteoarthritis, HipTraumatic Arthritis of HipNCT00588861Biomet Orthopedics, LLC400
已完成
不适用
Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance StudyPrimary OsteoarthritisSecondary OsteoarthritisPrimary Total Hip Replacement (THR)Avascular NecrosisNCT04425603Smith & Nephew Orthopaedics AG270