| CTRI Number |
CTRI/2025/06/089172 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Study (Mixed Method) |
| Study Design |
Other |
|
Public Title of Study
|
Fracture injuries and their referral pathways in rural and urban health centers of Raigad district |
|
Scientific Title of Study
|
Prevalence, referral pathways and first response for injuries causing fractures in rural and urban primary health care centres of Panvel Taluka: A Descriptive study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritty Thomas PT |
| Designation |
MPT Scholar |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector 1, Kamothe, Navi Mumbai – 410209, Maharashtra, India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
7039852234 |
| Fax |
|
| Email |
rthomas@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor, Director |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector 1, Kamothe, Navi Mumbai – 410209, Maharashtra, India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajani.kanade@googlemail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor, Director |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector 1, Kamothe, Navi Mumbai – 410209, Maharashtra, India
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajani.kanade@googlemail.com |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy MGM Institute of Health Sciences, Navi Mumbai
|
|
|
Primary Sponsor
|
| Name |
Dr.Ritty Thomas (PT) |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector 1, Kamothe, Navi Mumbai – 410209, Maharashtra, India |
| Type of Sponsor |
Other [Constituent unit of deemed to be university] |
|
|
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 |
| Dr Rajani Mullerpatan |
MGM Institute of Health Sciences,Kamothe |
MGM Institute of Health Sciences, Sector 1, Kamothe, Navi Mumbai – 410209, Maharashtra, India
Raigarh
MAHARASHTRA |
02227437866
rajani.kanade@googlemail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee – MGM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S42||Fracture of shoulder and upper arm, (2) ICD-10 Condition: S52||Fracture of forearm, (3) ICD-10 Condition: S62||Fracture at wrist and hand level, (4) ICD-10 Condition: S72||Fracture of femur, (5) ICD-10 Condition: S82||Fracture of lower leg, including ankle, (6) ICD-10 Condition: S92||Fracture of foot and toe, except ankle, (7) ICD-10 Condition: S32||Fracture of lumbar spine and pelvis, (8) ICD-10 Condition: S02||Fracture of skull and facial bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants with a history of Fractures of spine, upper and lower extremity
2 Patients referred from one facility to another for fracture management
3 Caregivers and healthcare professionals involved in the referral process
4 Accredited Social Health Activist (ASHA) workers, Resident Medical Officer (RMO), Sarpanch (gram panchayat) and Auxiliary Nurse Midwife (ANM) who are involved in healthcare
|
|
| ExclusionCriteria |
| Details |
1 Individuals who do not consent to participate
2 Patients with cognitive impairments
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Screening tool- Semi structured questionnaire |
Not applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
|
|
|
Target Sample Size
|
Total Sample Size="7472"
Sample Size from India="7472"
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)
|
01/08/2025 |
| 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)
|
Not Applicable |
| 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
|
This descriptive study aims to study the prevalence, first response of care
and referral pathways for injuries caused by fractures in two urban and rural
primary health centres of Raigad district. Data will be collected via interview
using a validated screening tool to address the objectives. The tool includes
questions regarding the details relevant to understand if there are any gaps in
the availability of medical care following the injury and reasons for the same.
Quantitative data will be analysed using count and frequency, whereas
qualitative data will be analysed using the thematic analysis method |