| CTRI Number |
CTRI/2024/11/076398 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
PROBLEMS FACED IN HIP FRACTURES IN ELDERLY
|
|
Scientific Title of Study
|
EVALUATION OF THE BURDEN ON HOSPITAL HEALTH
CARE FACILITIES DUE TO GERIATRIC HIP FRACTURES
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARSHIT KULSHRESHTHA |
| Designation |
post graduate student |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Department OF Orthopaedics ,MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG ,NEW DELHI -110002
New Delhi
DELHI
110002
India |
| Phone |
8929422148 |
| Fax |
|
| Email |
harshitkulshreshtha27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUMIT SURAL |
| Designation |
Director professor |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ORTHOPAEDICS ,MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG ,NEW DELHI -110002
New Delhi
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 |
| Address |
DEPARTMENT OF ORTHOPAEDICS ,MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG ,NEW DELHI -110002
New Delhi
DELHI
110002
India |
| Phone |
9968604323 |
| Fax |
|
| Email |
sumitsural@hotmail.com |
|
|
Source of Monetary or Material Support
|
| LOK NAYAK HOSPITAL,NEW DELHI,PIN-110002 |
|
|
Primary Sponsor
|
| Name |
DELHI GOVERNMENT |
| Address |
DEPARTMENT OF ORTHOPAEDICS LOK NAYAK HOSPITAL NEW DELHI PIN-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 |
| DR SUMIT SURAL |
Lok Nayak Hospital |
ward 3a,3b,4a,4b,5a,5b DEPARTMENT OF ORTHOPAEDICS LOK NAYAK HOSPITAL NEW DELHI
Central
DELHI |
9968604323
sumitsural@hotmail.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: S721||Pertrochanteric fracture, (2) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Intracapsular fracture neck femur
Intertrochanteric fracture neck femur |
|
| ExclusionCriteria |
| Details |
Pathological hip fractures
Patient of unsound mind or undergoing psychiatric treatment.
Polytrauma patient. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of length of stay with separate record of preoperative and postoperative stay will
be done |
At baseline
Average length of hospital stay
Total duration of engagement of the operation
theater for the surgical management to be done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of operative time required for the surgical management
The various surgical implants needed for the management of hip fractures.
The type of non-operative treatment required for the management of hip
fractures.
To evaluate the different types of investigations needed for care of these
patients. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
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)
|
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
|
Geriatric hip fractures present not only as a significant cause of morbidity and mortality to the elderly population but also as an important source of financial burden due to the staggering costs of hospitalization, medications, and implants, and productivity losses. With the growing aging population across the globe and the concomitant increase in the incidence of osteoporosis, there is an increasing interest in the field of fragility hip fractures and its economic burden to various countries so we analyse the burden of geriatric hip fractures in this study |