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10003 PRO Current Products (10003)

2019年4月19日 更新者：DePuy Orthopaedics

Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance

This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations from different manufacturers will be pooled to establish a contemporary dataset.

The primary objective of this study is to evaluate the functional performance as measured by the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year post-operation. This will be carried out for all four implant configurations. The final endpoint is a 2-year evaluation.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The study is designed as a prospective, single arm stratified, multi-center investigation.

Approximately 20 study sites, worldwide, will enroll 840 patients (840 knees). Each study site is expected to enroll approximately 42 patients (42 knees). Cohort reallocation is permitted. There will be no control group. Eight hundred forty (840) Subjects will be stratified into 4 subgroups of 210: fixed bearing cruciate retaining (FB CR), fixed bearing posterior stabilized (FB PS), rotating platform cruciate retaining (RP CR), and rotating platform posterior stabilized (RP PS).

Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

研究类型

观察性的

注册 (实际的)

842

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

  • 新西兰
      • Auckland、新西兰
        • Ascot Hospital
  • 澳大利亚
    • New South Wales
      • Hornsby、New South Wales、澳大利亚、2077
        • Hornsby Ku-Ring-Gai Hospital
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Wakefield Orthopedic Clinic
    • Western Australia
      • Crawley、Western Australia、澳大利亚、6009
        • Freemantle Hospital
      • Perth、Western Australia、澳大利亚、6000
        • Royal Perth Hospital
  • 美国
    • California
      • Orange、California、美国、92868
        • Orthopaedic Specialty Institute
      • San Diego、California、美国、92103
        • UCSD Medical Center
    • Colorado
      • Fort Collins、Colorado、美国、80525
        • Orthopaedic Center of the Rockies
    • Florida
      • Jacksonville、Florida、美国、32205
        • Heekin Institute for Orthopedic Research
    • Kentucky
      • Louisville、Kentucky、美国、40215
        • The Arthroplasty Foundation
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Tulane University Hospital and Clinic
    • Nevada
      • Las Vegas、Nevada、美国、89128
        • Hip and Knee Research of Nevada
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
    • Ohio
      • Columbus、Ohio、美国、43213
        • Cardinal Orthopaedic Institute
    • Virginia
      • Alexandria、Virginia、美国、22307-9804
        • Anderson Orthopaedic Research Institute
    • Washington
      • Seattle、Washington、美国、98122-5330
        • Swedish Orthopedic Institute
  • 英国
      • Harlow、英国、CM20 1QX
        • Princess Alexandra Hospital
      • Llandough、英国、CF64 2XX
        • University Hospital Llandough
      • Middlesborough、英国、TS4 3BW
        • James Cook University Hospital
      • York、英国、YO30 5RA
        • Clifton Park NHS Treatment Centre
    • Fife
      • Dunfermline、Fife、英国、KY12 OSU
        • Queen Margaret Hospital
    • Surrey
      • Guildford、Surrey、英国、GU2 7XX
        • The Royal Surrey County Hospital

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

22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

取样方法

非概率样本

研究人群

Male and female Subjects with Non-inflammatory Degenerative Joint Disease (NIDJD) who require primary TKA with one of several designated knee systems currently on the market and are aged 22 to 80 years, inclusive.

描述

Inclusion Criteria:

  • Subject is male or female and between the ages of 22 and 80 years, inclusive.
  • Subject was diagnosed with NIDJD.
  • Subject is a suitable candidate for cemented primary TKA using the devices described in this CIP with either a resurfaced or non-resurfaced patellae.
  • Subject's TKA device was one of the total knee prostheses described under Interventions.
  • Subject is currently not bedridden.
  • Subject has given voluntary, written informed consent to participate in this clinical investigation, is willing and able to perform all study procedures and follow-up visits and has authorized the transfer of his/her information to DePuy.
  • Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
  • Subject must be comfortable with speaking, reading, and understanding questions and providing responses in English.
  • The devices specified in this CIP were implanted.

Exclusion Criteria:

  • The Subject is a woman who is pregnant or lactating.
  • Contralateral knee has already been enrolled in this study.
  • Subject had a contralateral amputation.
  • Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
  • Subject is currently experiencing radicular pain from the spine.
  • Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
  • Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
  • Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
  • Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
  • Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
  • Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
  • Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
  • Subject has a medical condition with less than 2 years of life expectancy.

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

队列和干预

团体/队列
干预/治疗
CR FB
Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration
设备：Total Knee Replacement

Subjects will receive one of the following total knee implants:

PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
PS FB
Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration
设备：Total Knee Replacement

Subjects will receive one of the following total knee implants:

PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
CR RP
Subjects receiving a Cruciate Retaining Rotating Platform implant configuration
设备：Total Knee Replacement

Subjects will receive one of the following total knee implants:

PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
PS RP
Subjects receiving a Posterior Stabilized Rotating Platform implant configuration
设备：Total Knee Replacement

Subjects will receive one of the following total knee implants:

PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.

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
Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score
大体时间：up to one year
The primary endpoint will be measuerd before surgery and out to a minimum of 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee-related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
up to one year

次要结果测量

结果测量
措施说明
大体时间
Evaluate the psychometric properties of PKIP
大体时间：Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
The Pre and Post-Surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.
Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate the longitudinal functional performance of primary TKA
大体时间：< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate Incidence of Anterior Knee Pain
大体时间：Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate incidence of asymptomatic and symptomatic crepitus
大体时间：Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate patients functional performance for PS knees, CR knees, FB knees, and RP knees
大体时间：< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)

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

DePuy Orthopaedics

调查人员

  • 研究主任：Ahmad S. Ismail, MS, CCRP、DePuy Orthopaedics

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2011年10月1日

初级完成 (实际的)

2018年8月10日

研究完成 (实际的)

2018年8月10日

研究注册日期

首次提交

2011年12月20日

首先提交符合 QC 标准的

2011年12月21日

首次发布 (估计)

2011年12月22日

研究记录更新

最后更新发布 (实际的)

2019年4月22日

上次提交的符合 QC 标准的更新

2019年4月19日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 10003

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