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临床试验/CTRI/2025/12/098706
CTRI/2025/12/098706尚未招募不适用

Integrating existing hand injury scoring systems to develop an artificial intelligence-based algorithm utilizing electronic health records , for prognostication of hand and upper limb injury outcomes

bimal varghese Balu1 个研究点 分布在 1 个国家目标入组 1,112 人开始时间: 2025年12月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,112
试验地点
1
主要终点
Electronic health record for Acute hand and upper limb injury

研究概览

简要总结

Background

Hand and upper limb trauma constitutes a major proportion of emergency presentations and is

frequently associated with significant functional disability, socioeconomic burden, and prolonged

rehabilitation. Over the years, several injury scoring systems have been developed, including the

Strickland Digital Scoring System, Hand Injury Severity Score (HISS), Modified Hand Injury Severity

Score (MHISS), Duncan’s classification, Tulipan’s classification, Pichitchai’s infection risk score, and

the Mangled Upper Extremity Score (MUES). While these systems provide structured frameworks for

assessing injury severity, they evaluate injuries in isolation and are limited by inter-observer variability

and lack of holistic assessment. With advances in electronic health records (EHR) and artificial

intelligence (AI), there is an opportunity to integrate multiple scoring systems into a unified, data-driven

platform capable of providing comprehensive prognostication and guiding clinical decision-making.

Aims and Objectives

The aim of this study is to integrate existing hand injury scoring systems into an AI-based algorithm

within an EHR platform, in order to improve prognostication and outcome prediction in hand and upper

limb trauma. The objectives are: 1. To develop an electronic health record for Acute hand and upper

limb injury 2. To identify dominant parameters that influence the score from multiple scoring system

using feature engineering from machine learning 3. To develop a comprehensive score using AI based

algorithms from the identified dominant parameters

Methodology

This study follows a prospective design with a five-year retrospective component. Retrospective data

from 1112 patients with acute hand and upper limb trauma and prospective data from approximately

120 patients presenting to Kasturba Hospital, Manipal, are included. Data are collected using the

standardized acute hand injury sheet and digitized into an institutional EHR with secure cloud storage.

Patient identifiers are anonymized before integration with the computational platform. Existing scoring

systems are embedded within the EHR, and AI models are developed using Google Colab with

TensorFlow and Keras. Regression analysis and iterative training are used to identify dominant

prognostic variables. The retrospective dataset is used for training and testing, while the prospective

cohort serves as validation. Statistical analysis is performed using SPSS version 23.0, with Chi-square

tests for categorical variables and t-tests or ANOVA for continuous variables, with significance set at p

< 0.05.

Discussion/ROL

The literature highlights the progressive development of hand injury scoring methods but also their

limitations. Strickland’s early scoring system provided thresholds for digital salvage but did not account

for microsurgical advances. Campbell and Kay’s HISS correlated with return-to-work outcomes but

excluded vascular and forearm injuries. Urso and colleagues refined this with MHISS, which predicted

return-to-work more effectively but still lacked full prognostic capacity. Tulipan and Atthakomol

introduced classification systems for open fractures that addressed infection risk, while Savetsky’s

MUES attempted to quantify outcomes in mangled extremities. Despite these contributions, no single

system comprehensively captures all injury domains. Artificial intelligence offers a solution by

integrating diverse parameters into a reproducible predictive framework. Preliminary analyses indicate

that an AI-based comprehensive score improves predictive accuracy over traditional systems, reduces

subjectivity, and provides faster decision support in emergency settings. Beyond clinical applications,

the platform standardizes documentation, facilitates data sharing, and offers potential for multicentric

research and commercialization.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients that presenting to kasturba medical college Hospital with hand or upper limb injury.

排除标准

  • Incomplete medical records.

结局指标

主要结局

Electronic health record for Acute hand and upper limb injury

时间窗: The study utilizes variable time points depending on the specific prediction target. Immediate (at presentation): Assessing injury severity, surgical timing, and amputation vs. salvage necessity. Intermediate (early post-op): Predicting risk of infection requiring re-debridement. Long-term: Forecasting functional range of movement. These outcomes are validated throughout the 8-month prospective study period.

次要结局

  • Comprehensive score using AI based algorithms from the identified dominant parameters(5 months)
  • Identify dominant parameters that influence the score from multiple scoring system using feature engineering from machine learning(5 months)

研究者

发起方
bimal varghese Balu
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Bimal Varghese Balu

Kasturba Medical College (KMC), Manipal

研究点 (1)

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