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A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System

2012年10月9日 更新者:Smith & Nephew, Inc.

A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental Knee System

This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee System and is intended to evaluate the safety and effectiveness of the new device.

研究概览

地位

完全的

条件

详细说明

The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System. Patients will be examined clinically at time intervals throughout the study duration. Exams will include completion of clinical assessment, x-rays, and completion of patient questionnaires.

研究类型

观察性的

注册 (实际的)

59

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

    • Florida
      • Vero Beach、Florida、美国、32860
        • Orthopaedic Center of Vero Beach
    • Illinois
      • Park Ridge、Illinois、美国、60068
        • Orthopaedic Surgery Specialists, Ltd.
    • Indiana
      • New Castle、Indiana、美国、47362
        • Henry County Center for Orthopedic Surgery & Sports Medicine
    • Iowa
      • Des Moines、Iowa、美国、50314
        • Iowa Orthopaedic Center, PC

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

30年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The patients eligible for this study are non-inflammatory degenerative joint disease patients requiring a primary unilateral knee surgery. The affected areas must be limited to the medial and patellofemoral compartments.

描述

Inclusion Criteria:

  • Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
  • Patient is 30 to 75 years of age, inclusive.
  • Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
  • Patient plans to be available for follow-up through five years postoperative.

Exclusion Criteria:

  • Patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders.
  • Patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (AIDS).
  • Patient has inflammatory arthritis (e.g. rheumatoid arthritis)
  • Patient has BMI greater than or equal to 40.
  • Patient has had major knee surgery in the past i.e. HTO, unicondylar knee replacement, failed fracture fixation.
  • Patient has an active infection, local or systemic.
  • Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and followup (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
  • Patient has ACL deficiency in the study knee.
  • Patient has hip arthritis and/or replacement.
  • Patient has lateral compartment disease.
  • Patient is pregnant or plans to become pregnant during the course of the study.
  • Patient has a known sensitivity to materials in the device.

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

  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Knee Society Score
大体时间:Preoperative-2 years
Assess knee pain, function and range of motion using the Knee Society Clinical Rating System
Preoperative-2 years

次要结果测量

结果测量
措施说明
大体时间
Oxford Knee Outcome Questionnaire
大体时间:Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years
Patient evaluation of function
Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years
Radiographic Evaluation
大体时间:6 weeks, 1 year and 2 years
X-rays will be assessed for evidence of implant loosening, surface wear, migration or any other clinical or radiographic abnormalities.
6 weeks, 1 year and 2 years
Patient Satisfaction
大体时间:6 weeks, 3 months, 6 months, 1 year and 2 years
Patient satisfaction questionnaire to be completed at each follow-up visit
6 weeks, 3 months, 6 months, 1 year and 2 years
Adverse Events
大体时间:When Necessary
All intra-operative, discharge, and post-operative surgical/hospitalization or study knee-related adverse events will be captured during the study to assess for safety issues.
When Necessary

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。

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

2006年9月1日

初级完成 (实际的)

2012年2月1日

研究完成 (实际的)

2012年5月1日

研究注册日期

首次提交

2012年9月24日

首先提交符合 QC 标准的

2012年10月9日

首次发布 (估计)

2012年10月11日

研究记录更新

最后更新发布 (估计)

2012年10月11日

上次提交的符合 QC 标准的更新

2012年10月9日

最后验证

2012年10月1日

更多信息

与本研究相关的术语

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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