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CTRI Number  CTRI/2025/12/098706 [Registered on: 09/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   Creating a Unified Scoring System for Better Management of Complex Hand Injuries using AI 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bimal Varghese Balu 
Designation  Senior Resident 
Affiliation  Kasturba Medical College (KMC), Manipal 
Address  Department of Hand Surgery , Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Department of Hand Surgery , Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India 
Phone  9646152614  
Fax    
Email  bimalbalu143@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil K. Bhat 
Designation  Dean and Professor 
Affiliation  Kasturba Medical College (KMC), Manipal 
Address  Department of Hand Surgery , Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Department of Hand Surgery , Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India 
Phone  9008419336  
Fax    
Email  anil.bhat@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Bimal Varghese Balu 
Designation  Senior Resident 
Affiliation  Kasturba Medical College (KMC), Manipal 
Address  Department of Hand Surgery , Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Department of Hand Surgery , Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India 
Phone  9646152614  
Fax    
Email  bimalbalu143@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  bimal varghese Balu 
Address  Department of Hand Surgery, Kasturba Hospital, Manipal,Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bimal Varghese Balu  Kasturba Medical College, Manipal  Department of Hand Surgery , Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 Department of Hand Surgery , Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 
9646152614

bimalbalu143@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and Kasturba hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S60-S69||Injuries to the wrist, hand and fingers, (2) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, (3) ICD-10 Condition: S40-S49||Injuries to the shoulder and upper arm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients that presenting to kasturba medical college Hospital with hand or upper limb injury 
 
ExclusionCriteria 
Details  Incomplete medical records 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Electronic health record for Acute hand and upper limb injury

 
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.

 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="1112"
Sample Size from India="1112" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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.
 
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