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临床试验/CTRI/2026/02/104353
CTRI/2026/02/104353尚未招募不适用

INTER AND INTRA-OBSERVER RELIABILITY OF ACCUBALANCE GRAPH ASSESSMENT IN IMAGELESS ROBOTIC-ASSISTED TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE OBSERVATIONAL STUDY

Ganga hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年3月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1

研究概览

简要总结

Robotic-assisted total knee arthroplasty has emerged as a

technology to enhance surgical precision and soft tissue balancing.

Imageless robotic-assisted total knee arthroplasty has enabled

objective, real-time assessment of knee balance throughout the

range of motion

These systems provide quantitative intra-operative feedback

through graphical representations of medial and lateral

compartment gaps, commonly displayed as balance graphs

While the accuracy of these robotic systems is noted, the reliability

of balance graph interpretation by different observers and by the

same observer over time remains underexplored.

This prospective observational study aims to assess the

inter-observer and intra-observer reliability of AccuBalance graph

assessment in imageless robotic-assisted TKA, without disrupting

standard surgical workflows.

The study’s findings will support the validation of robotic balance

assessment tools for clinical use and research applications.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • primary TKA for osteoarthritis , complete accubalance graph data captured intraoperatively, preoperative deformity less than 20 degrees.

排除标准

  • revision total knee replacement , inflammatory arthritis , post traumatic arthritis, severe bone loss requiring augmentation, severe extra articular deformity , incomplete or technically inadequate accubalance recordings.

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Udhayaprakash Saminathan

Ganga hospital

研究点 (1)

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