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A Retrospective Study of the Navio Robotic-assisted Surgical System (NAVIO)

2022年5月2日 更新者:Smith & Nephew, Inc.

A Retrospective Study of the Navio™ Robotic-assisted Surgical System

A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control

研究概览

地位

完全的

详细说明

Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year safety and effectiveness of the Navio system.

研究类型

观察性的

注册 (实际的)

128

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

    • Arizona
      • Phoenix、Arizona、美国、85016
        • Hedley Orthopedics
    • California
      • Santa Barbara、California、美国、93105
        • Santa Barbara Cottage Hospital
    • Michigan
      • Battle Creek、Michigan、美国、49015
        • Bronson Orthopedic Specialists
    • Ohio
      • New Albany、Ohio、美国、43054
        • OrthoNeuro New Albany
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Rothman Institute

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

18年 及以上 (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

One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition

描述

Inclusion Criteria:

  1. Male or female subjects ≥ 18 years old (at the time of surgery) who have undergone Navio System-assisted UKR at least 2 years prior to enrollment. This includes UKR procedures with all Unicondylar Knee cemented implant designs.
  2. Subject had a primary diagnosis of unicompartmental, non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, required correction of functional deformity, or required treatment of fractures that were unmanageable using other techniques.

Exclusion Criteria:

  1. Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.
  2. Subject, in the opinion of the Investigator, had advanced osteoarthritis or joint disease at the time of surgery and was better suited for Total Knee Arthroplasty (TKA).
  3. Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.
  4. Subject, in the opinion of the Investigator, was morbidly obese.
  5. Subject, in the opinion of the Investigator, was contraindicated for UKR.
  6. Subject (prospective subjects only), in the opinion of the Investigator, has an emotional or neurological condition including mental illness, mental retardation, drug or alcohol abuse.
  7. Subject (prospective subjects only) is a prisoner.

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

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
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
大体时间:Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.
Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively

次要结果测量

结果测量
措施说明
大体时间
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
大体时间:Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively

Analysis of KSS from preoperatively (Baseline) up to 36 months postoperatively in 6-months increments to evaluate objective observation, patient satisfaction, and function.

Objective knee indicators: Range 0-100 points; Patient Satisfaction: Range 0-40 points; and Functional Activities: Range 0-100 points.

Higher scores indicated a better outcome.

Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
大体时间:Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively

Analysis of VR-12 scores preoperatively (Baseline) through 36 months postoperatively in 6 months increments. These scores encompass the individual domains of physical component score (PCS), mental component score (MCS) as well as the sub-domain scores within the PCS (physical functioning, role physical, bodily pain, and general health) and those within the MCS (vitality, social functioning, role emotional, and mental health).

Domain Scores:

Physical Component Score (PCS): Range 1 to 20 Mental Component Score (MCS): Range 1 to 25

Sub-domain Scores:

Physical Functioning: Range 1 to 6 Role Physical: Range 1 to 4 Bodily Pain: Range 1 to 6 General Health: Range 1 to 6 Vitality: Range 1 to 6 Social Functioning: Range 1 to 6 Role Emotional: Range 1 to 4 Mental Health: Range 1 to 10

Transformation of raw scale scores (range 0-100) = {(actual raw score - lowest possible raw score)/possible raw score range} x100

A higher score indicates a better outcome.

Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
Preoperative Evaluation of Efficacy Based on Radiographic Findings
大体时间:Preoperative (Baseline)
Changes in radiographic findings (anterior-posterior [AP] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Preoperative (Baseline)
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
大体时间:6 months postoperatively
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
6 months postoperatively
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
大体时间:12 months postoperatively
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
12 months postoperatively
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
大体时间:18 months postoperatively
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
18 months postoperatively
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
大体时间:24 months postoperatively
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
24 months postoperatively
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
大体时间:30 months postoperatively
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
30 months postoperatively
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
大体时间:36 months postoperatively
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
36 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。

调查人员

  • 研究主任:Beate Hanson, MD, PhD、Smith & Nephew, Inc.

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)

2017年7月10日

初级完成 (实际的)

2017年11月29日

研究完成 (实际的)

2017年11月29日

研究注册日期

首次提交

2017年3月2日

首先提交符合 QC 标准的

2017年3月2日

首次发布 (实际的)

2017年3月7日

研究记录更新

最后更新发布 (实际的)

2022年5月25日

上次提交的符合 QC 标准的更新

2022年5月2日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • 16-NPFS-11

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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