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临床试验/NCT06863428
NCT06863428已完成不适用

Concordance Between an App-based Range of Motion Measurement and Standard Goniometer.

Zimmer Biomet2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2025年11月21日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
Zimmer Biomet
入组人数
41
试验地点
2
主要终点
Active knee flexion

研究概览

简要总结

This prospective study aims to evaluate the agreement, also referred as concordance, of the mymobilty knee ROM with a clinician's assessment of knee ROM via goniometer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is a minimum of 18 years of age
  • Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent form

排除标准

  • The patient is currently participating in any other study that would hinder the assessor's ability to measure knee ROM
  • Complex primary knee pathology with significant restrictions on the range of motion per surgeon discretion
  • Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)

研究组 & 干预措施

Group 1

This group will have their knee range of motion measured three times. Once with the mymobility app, and twice using a goniometer by two separate assessors. Each assessor will be blinded to the other assessor's measurements.

结局指标

主要结局

Active knee flexion

时间窗: Day 1 (Single Visit)

Patients will be asked to sit in a chair to measure full active knee flexion.

Active knee extension

时间窗: Day 1 (Single Visit)

Patients will be asked to sit in a chair to measure full active knee extension.

Passive knee extension with overpressure

时间窗: Day 1 (Single Visit)

Patients will be asked to sit in a chair to measure full passive knee extension while applying overpressure on their knee with their hands.

次要结局

未报告次要终点

研究者

发起方
Zimmer Biomet
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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