| 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
|
|
|
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
|
|
|
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
|
|
|
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. |