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CTRI Number  CTRI/2024/11/076690 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   BURDEN ON HOSPITAL HEALTH CARE DUE TO ROAD TRAFFIC INJURIES 
Scientific Title of Study   EVALUATION OF THE BURDEN ON HOSPITAL HEALTH CARE DUE TO MUSCULOSKELETAL TRAUMA CAUSED BY ROAD TRAFFIC INJURIES 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranay kumar Singh 
Designation  Postgraduate resident 
Affiliation  Maulana azad medical college and associated hospital 
Address  Department of orthopedics, lok nayak hospital, new delhi-110002 Central DELHI
Department of orthopedics, lok nayak hospital, new delhi-110002 Central DELHI
Central
DELHI
110002
India 
Phone  9971863669  
Fax    
Email  pranay110796@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumit sural 
Designation  Director professor 
Affiliation  Maulana azad medical college and associated hospital 
Address  Department of orthopedics, lok nayak hospital, new delhi-110002 Central DELHI
Department of orthopedics, lok nayak hospital, new delhi-110002 Central DELHI
Central
DELHI
110002
India 
Phone  9968604323  
Fax    
Email  sumitsural@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sumit sural 
Designation  Director professor 
Affiliation  Maulana azad medical college and associated hospital 
Address  Department of orthopedics, lok nayak hospital, new delhi-110002 Central DELHI
Department of orthopedics, lok nayak hospital, new delhi-110002 Central DELHI

DELHI
110002
India 
Phone  9968604323  
Fax    
Email  sumitsural@hotmail.com  
 
Source of Monetary or Material Support  
lok Nayak hospital 
 
Primary Sponsor  
Name  Lok nayak hospital 
Address  lok Nayak hospital, near Delhi gate, New Delhi, India 110002 
Type of Sponsor  Government medical college 
 
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 
Pranay kumar singh  Lok nayak hospital  department of orthopedics, Lok Nayak Hospital, near Delhi gate, New Delhi
Central
DELHI 
9971863669

pranay110796@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana azad medical college Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age group of 18-80 years.
Patients admitted within 24 hours of musculoskeletal injury.
Patients who remain admitted for more than 3 days.
 
 
ExclusionCriteria 
Details  Patients with only soft tissue injuries.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Average length of hospital stay
Total duration of engagement of the operation theater for the surgical management.
 

1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Burden on the hospital system due to the requirement of all routine & specialized investigations & their repetition (Blood & radiological investigations).
Utilization of all pharmacological & non operative treatment modalities.
The outcome parameters mentioned above will be correlated to the type of victim of the road traffic injury, whether pedestrian or in a vehicle occupant (driver or passenger). 
1 year 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   16/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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)   Open to Recruitment 
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  

Musculoskeletal trauma caused due to road traffic injuries is one of the major contributors of patient load in most hospitals. Every year, according to the statistics, 1.2 million people are known to die in road accidents worldwide. Millions of others sustain injuries, with some suffering permanent disabilities. No country is spared this toll in lives and suffering, which strikes the young particularly. Enormous human potential is being destroyed, with also grave social and economic consequences.

They have a significant socioeconomic burden in terms of hospital stay, need for several blood and radiological  investigations, the various surgical procedures needed for their management and the duration of utilization of the operation theater, the type of non-operative treatment required for the management of these injuries , involvement of health care workers, bed occupancy premature  deaths, injuries, and lost earning opportunities. Road traffic injuries (RTI) have  a detrimental  effect  on  the economy  in addition  to harming people’s  wellbeing and health. In terms of fatality causes, motor vehicle accidents were ninth (9th) in 2004 and are  expected to  reach fifth (5th) in 2030.1 

Pedestrians, passengers, and 2 wheeler users  are the road  users most frequently affected, as  contrast to drivers, who are primarily  responsible for most  fatalities and disability.

The quality of life & economic development in the area are expected to suffer significantly as a result of this rapidly spreading epidemic that targets the young, productive population. In the end, there has been a substantial loss of national wealth.

This study is to investigate the burden on hospital of musculoskeletal trauma caused due to road traffic injuries because there is very little literature on Indian scenarios.


 
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