| CTRI Number |
CTRI/2025/07/092063 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Comparative Study of Two Surgical Approaches (PFN vs PFNA2) for Treating Intertrochanteric Fractures: Examining Clinical Outcomes, Blood Loss, X-ray Exposure, and Surgical Time |
|
Scientific Title of Study
|
A prospective study to compare clinical, Radiological and intra-OP parameters such as blood loss, Fluroscopy exposure and surgical duration in intertrochanteric fracture managed with PFN and PFNA2 |
| 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 Singh Kavi Kailash |
| Designation |
Post MBBS DNB Resident |
| Affiliation |
Govt R D B P Jaipuria hospital , Jaipur |
| Address |
Room no 21/23 , Department of Orthopedics , Govt RDBP Jaipuria Hospital, Milap Nagar ,Jaipur Rajasthan 302018
House no 172, Guraniyo ki Gali , Near Gandhi Chowk Pokaran , Jaisalmer Rajasthan 345021
Jaipur
RAJASTHAN
302018
India |
| Phone |
9512991151 |
| Fax |
|
| Email |
kavisingh159@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Singh |
| Designation |
Assistant Professor |
| Affiliation |
Govt R D B P Jaipuria hospital attached to RUHS-CMS, Jaipur |
| Address |
94/201, Vijay Path, Jhalana Chhod,Mansrovar, Jaipur , Rajasthan
Department of Orthopedics Govt R D B P Jaipuria hospital, Jaipur
Jaipur
RAJASTHAN
302020
India |
| Phone |
9928312022 |
| Fax |
|
| Email |
dr.singhvarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Singh Kavi Kailash |
| Designation |
Post MBBS DNB Resident |
| Affiliation |
Govt R D B P Jaipuria hospital , Jaipur |
| Address |
Room no 21/23 Department of Orthopedics, Govt RDBP Jaipuria Hospitall, Milap Nagar Jaipur 302018
House no 172, Guraniyo Ki Gali , Near Gandhi Chowk Pokaran Jaisalmer 345021
Jaipur
RAJASTHAN
302018
India |
| Phone |
9512991151 |
| Fax |
|
| Email |
kavisingh159@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt R D B P Jaipuria Hospital attached RUHS-CMS , Jaipur 302018 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 Singh Kavi Kailash |
Govt RDBP Jaipuria Hospital attached toRUHS Hospital Jaipur |
Room No 21/23 Department Of Orthopedics, Govt RDBP Jaipuria Hospital, Milap Nagar , Jaipur 302018
Jaipur
RAJASTHAN |
9512991151
kavisingh159@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee RUHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PFN(Proximal Femur Nail) |
It is a metallic implant used for fixation of Intertrochanteric Femur fracture, having 2 proximal screws( Compression screw and Antirotation screw) |
| Comparator Agent |
PFNA2 ( Proximal Femur Nail Antiroation Asian) |
It is metallic implant, used in IT fracture and having 1 Helical blade for fixation. In head. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Skeletally mature patients more than 18 years age
Patients with intertrochanteric fracture with closed fracture and pre-trauma ambulatory patients |
|
| ExclusionCriteria |
| Details |
patients with pathological fracture excepts osteoporosis
patient with pre-existing hip pathology and non-ambulatory before trauma and medically unfit for surgery
Intertrochanteric femur fracture associated with shaft of femur or Tibia fracture
Fracture associated with neurovascular deicits
Sub trochanteric, reverse oblique, cericotrochanteric and fracture intracapusular NOF |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional outcome in terms of modified Harris Hip Score
Union time of fracture
intra-op blood loss, IITV exposure,Surgery time |
6 month post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post surgery complications |
post operative follow up till 6months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/08/2025 |
| 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) |
Open to Recruitment |
|
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
|
The patients included in the study would be those scheduled for elective surgery of intertrochanteric femur fracture manage with PFN and PFNA2 , will compare clinical outcome with help of modified Harris Hip Score and radiological outcome with help of union time and intraoperative blood loss , IITV exposure in term of toal IITV shots and total Surgery time . |