| CTRI Number |
CTRI/2024/11/077141 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Association of bone quality and fracture pattern in intertrochanteric femur fracture in adults: A CT scan study |
|
Scientific Title of Study
|
Association of bone quality measured as determined by NCCT scan and 3D CT based fracture pattern in intertrochanteric femur fracture in adults. |
| 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 Saumya Kullu |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute Of Medical Sciences |
| Address |
Department of Orthopaedics,Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand 834009
Ranchi
JHARKHAND
834009
India |
| Phone |
7903382805 |
| Fax |
|
| Email |
kullu.saumya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govind Kumar Gupta |
| Designation |
Additional Professor |
| Affiliation |
Rajendra Institute Of Medical Sciences |
| Address |
Department of Orthopaedics,Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand 834009
Ranchi
JHARKHAND
834009
India |
| Phone |
7979014287 |
| Fax |
|
| Email |
gkgupta1975@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Govind Kumar Gupta |
| Designation |
Additional Professor |
| Affiliation |
Rajendra Institute Of Medical Sciences |
| Address |
Department of Orthopaedics,Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand 834009
Ranchi
JHARKHAND
834009
India |
| Phone |
7979014287 |
| Fax |
|
| Email |
gkgupta1975@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute Of Medical Sciences, Bariatu, Ranchi, Jharkhand, India. Pin code- 834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute Of Medical Sciences |
| Address |
Department of orthopaedics, Rajendra Institute Of Medical Sciences, Bariatu, Ranchi, Jharkhand - 834009 |
| 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 Saumya Kullu |
Rajendra Institute Of Medical Sciences |
Department of Orthopaedics,Rajendra Institute Of Medical Sciences, Bariatu, Ranchi, Jharkhand 834009
Ranchi
JHARKHAND |
7903382805
kullu.saumya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RIMS, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S721||Pertrochanteric fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
(a) The patient giving written and informed consent for the study (b)The patient having intertrochanteric femur fracture (c) male and female patients between 18 to 75 years of age |
|
| ExclusionCriteria |
| Details |
(a) patient who is not between the age of 18 to 75 years and who does not give written and informed consent for the study (b) patient with open injuries (c) patient with pathological fracture (d) patient with previous history of any major Orthopaedic operation of the involved limb |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| (a)To evaluate the bone quality determined by NCCT scan in intertrochanteric femur fracture in adults (b)to find out correlation of Hounsfield Unit with 3D CT based fracture pattern in intertrochanteric femur fracture (c) to assess the correlation of Hounsfield Unit values of proximal femur with age |
1 week after admission of the patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| (b) to evaluate the association of bone quality & CT based fracture pattern in intertrochanteric femur fracture in adults (b)to find out correlation of Hounsfield unit with CT based fracture pattern in intertrochanteric femur fracture in adults (c) to determine the association of age & CT based fracture pattern in intertrochanteric femur fracture in adults |
one week after admission of the patient |
|
|
Target Sample Size
|
Total Sample Size="137"
Sample Size from India="137"
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)
|
02/12/2024 |
| 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
|
Hip fracture is one of the most common types of fracture in humans, particularly in the elderly with osteoporosis and young adults with high velocity trauma.It is reported that intertrochanteric fracture is the most common type of hip fractures and the number of patients increases with the age of the population. Computed tomography scans have been considered gold standard to asses bone morphology. They facilitate better understanding of the fracture pattern and therefore improve pre-operative planning and hence the outcome of fracture management. The most commonly used classifications for intertrochanteric femur fracture are Evans , Jensen and AO/OTA classifications which are based on two dimensional X-ray images which were found to have shortcomings in describing the actual fracture morphology and fracture stability, resulting in reduced diagnostic accuracy. Role of posteromedial column, lateral column and identifying unstable fracture can improve better choice of implant and fixation technique. We aim to evaluate the bone quality of proximal femur by Hounsfield unit in CT scan and its correlation with age and type of fracture pattern in intertrochanteric femur fracture in adults. |