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A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China

2018年4月3日 更新者：Johnson & Johnson Medical (Suzhou) Ltd.

A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Hip Arthroplasty Devices Manufactured in China Versus Devices Manufactured Outside of China

A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.

研究概览

地位

完全的

条件

干预/治疗

详细说明

A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Hip Arthroplasty Devices Manufactured in China versus Devices Manufactured Outside of China

研究类型

介入性

注册 (实际的)

160

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国
        • The first affiliated hospital of Guangzhou Tranditional Meidical University
    • Hebei
      • Shijiazhuang、Hebei、中国
        • The third affiliated hospital of Hebei University
    • Heilongjiang
      • Harbin、Heilongjiang、中国
        • The second affiiliated hospital of Harbin Medical University
    • Jiangxi
      • Nanchang、Jiangxi、中国
        • The First Affiliated Hospital of Nanchang University
    • Ningxia
      • Yinchuan、Ningxia、中国
        • The affiliated hosoital of Ningxia Medical University
    • Xinjiang
      • Hohhot、Xinjiang、中国
        • The First Affiliated Hospital of Xinjiang Medicine University
    • Yunnan
      • Kunming、Yunnan、中国
        • The general hospital of Kunming
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • The Second Affiliated Hospital of Zhejiang Medicine University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. The subject is ≥55, and ≤80 years old
  2. The Subject must be of Chinese ethnic descent and be willing to return on three occasions for clinical evaluations.
  3. Subject is a suitable candidate for primary total hip replacement using the devices described in this CIP
  4. Subject must meet all criteria specified in BOTH SUN hip stem and Summit hip stem instructions for use (IFU)
  5. Before surgery, subject is willing and able to sign the informed consent form approved by the Institutional Review Board (IRB), Ethics Committee (EC) or Ethical Review Board (ERB).
  6. Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
  7. Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the patient reported outcomes (PROs) in the CIP.
  8. Subject is receiving a unilateral hip replacement or, if a contralateral hip replacement is anticipated, the surgery must occur within 6 months of the first study hip. The second hip will not be enrolled in the study.

Exclusion Criteria:

  1. Subject does not provide written voluntary consent to participate in the clinical study.
  2. The Subject is a woman who is pregnant or lactating.
  3. Subjects who have undergone THA in contralateral hip within the past 6 months.
  4. Contralateral hip has been enrolled in the study.
  5. Presence of any previous prosthetic hip replacement device in affected hip.
  6. Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the affected hip
  7. Subject has hip dysplasia CROWE classification grade of 3 or 4.
  8. Above knee amputation of either contralateral or ipsilateral leg
  9. Subject is anticipated to require a contralateral THA between 6 months and 1-year.
  10. Subject has an active infection
  11. Subject has a malignant disease, severe condition, alcohol or drug addiction and/or mental disorders that the investigator believes will interfere with the study participation.
  12. Subjects with severe osteoporosis, metabolic bone disease, radioactive bone disease or tumor in the bone surrounding the hip joint that, in the opinion of the investigator, will negatively impact implant fixation and the outcome of the investigation;
  13. Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease).
  14. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
  15. Subject has a medical condition with less than 2 years of life expectancy due to other medical conditions.
  16. The patient has comorbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
  17. The patient is currently participating in another investigational drug or device study.
  18. Subject is a prisoner.
  19. Subject has a known allergy to any component of the implant (metal for example).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Total Hip System made in China
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured in China
设备：Total Hip System made in China (SUN, CoCr, Duraloc, Marathon)
SUN Hip stem,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
有源比较器：Total Hip System made outside of China
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured Outside of China
设备：Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)
Summit Porocoat STD,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Harris Hip Total Score at 12 months postoperatively
大体时间：12 months postoperatively
12 months postoperatively

次要结果测量

结果测量
大体时间
一年未翻修率，其中翻修定义为移除继发于感染的任何组件
大体时间：术后12个月
术后12个月
One year non-revision rate where revision is defined as removal of any component for any reason with the exception of infection
大体时间：12 months postoperatively
12 months postoperatively

其他结果措施

结果测量
措施说明
大体时间
Harris Hip Total Score success: success is ≥ 80 points.
大体时间：12 months postoperatively
12 months postoperatively
Patient Reported Outcomes
大体时间：Preoperation to 12 months postoperatively
SF 12: scores at 1 yr, change from pre-op. WOMAC: scores at 1 yr., change from pre-op.
Preoperation to 12 months postoperatively
Radiographs: incidence of clinically relevant radiolucent lines, and osteolysis
大体时间：Preoperation to 12 months postoperatively
Preoperation to 12 months postoperatively
Adverse Events: tally the type and frequency of adverse events
大体时间：Preoperation to 12 months postoperatively
Preoperation to 12 months postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Johnson & Johnson Medical (Suzhou) Ltd.

调查人员

  • 首席研究员：Shigui Yan、The Second Affiliated Hospital of Zhejiang Medicine University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年6月7日

初级完成 (实际的)

2017年12月4日

研究完成 (实际的)

2018年1月17日

研究注册日期

首次提交

2015年3月20日

首先提交符合 QC 标准的

2015年3月25日

首次发布 (估计)

2015年3月26日

研究记录更新

最后更新发布 (实际的)

2018年4月4日

上次提交的符合 QC 标准的更新

2018年4月3日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • DPS-201301

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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