| CTRI Number |
CTRI/2025/02/081055 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Clinical and Radiological Outcomes of Fixation with Proximal Femoral Nail (PFN) vs Proximal Femoral Nail-Antirotation 2(PFN A2) In Unstable Intertrochanteric Fractures of the Femur: A Randomised Comparative Study |
|
Scientific Title of Study
|
Comparison of Clinical Outcomes of Fixation with Proximal Femoral Nail (PFN) vs Proximal Femoral Nail-Antirotation 2(PFN A2) In Unstable Intertrochanteric Fractures of the Femur: A Randomised Comparative 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 |
Deepanjan Das |
| Designation |
Junior Resident, Department of Orthopaedics |
| Affiliation |
All India Institute of Medical Sciences, Nagpur |
| Address |
Department of Orthopaedics, AIIMS Nagpur, Plot number 2, sector 20, MIHAN
Nagpur
MAHARASHTRA
441108
India |
| Phone |
8961835790 |
| Fax |
|
| Email |
somdeepd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Samir Dwidmuthe |
| Designation |
Professor and Head, Department of Orthopaedics |
| Affiliation |
All India Institute of Medical Sciences, Nagpur |
| Address |
Department of Orthopaedics, AIIMS Nagpur, Plot number 2, sector 20, MIHAN
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9422904819 |
| Fax |
|
| Email |
samirdwidmuthe@aiimsnagpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Samir Dwidmuthe |
| Designation |
Professor and Head, Department of Orthopaedics |
| Affiliation |
All India Institute of Medical Sciences, Nagpur |
| Address |
Department of Orthopaedics, AIIMS Nagpur, Plot number 2, sector 20, MIHAN
MAHARASHTRA
441108
India |
| Phone |
9422904819 |
| Fax |
|
| Email |
samirdwidmuthe@aiimsnagpur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Nagpur, Plot number 2, Sector 20, MIHAN, Nagpur, 441108, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Deepanjan Das |
| Address |
Department of Orthopaedics, AIIMS Nagpur, Plot number 2, sector 20, MIHAN, Nagpur, 441108, Maharashtra, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Deepanjan Das |
All India Institute of Medical Sciences, Nagpur |
Room number 217, Department of Orthopaedics, OPD block, AIIMS Nagpur, Plot number 2, sector 20, MIHAN
Nagpur
MAHARASHTRA |
8961835790
somdeepd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Department of Pharmacology, All India Institute of Medical Sciences, Nagpur |
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 |
| Comparator Agent |
Open/ closed reduction and fixation with Proximal Femoral Nail (PFN) in unstable intertrochanteric fractures of the femur |
Surgical intervention for fracture, followed by postoperative rehabilitation |
| Intervention |
Open/ closed reduction and fixation with Proximal Femoral Nail-Antirotation 2(PFN A2) in unstable intertrochanteric fractures of the femur |
Surgical intervention for fracture, followed by postoperative rehabilitation |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with acute, unilateral, closed Intertrochanteric fractures of the femur, belonging to the unstable type (AO31A2, AO31A3).
2. Patients with mature skeleton
3. Patients aged between 50-80 years.
4. Patients who were independently ambulatory before the injury event
5. Willingness to participate in the study and forgo any other concomitant treatment modality with written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Immature skeleton
2. Pathological fractures
3. Open fractures
4. Inability to mobilize independently prior to injury event
5. Preexisting neuromuscular disorder
6. Patients unfit for undergoing surgery
7. Intracapsular fractures of the femur
8. Subtrochanteric fractures of the femur
9. Concomitant injuries, e.g., Head injury, other fractures etc.
10. Stable type of IT fractures of the femur
11. Not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intraoperative C arm shoots
Perioperative time
Blood loss
Reduction quality
Placement of screw/ blade
Post op functional status using Parker Palmer Mobility Score and Harris Hip Score |
2 weeks, 6 weeks, 3 months and 6 months post-surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications associated with either implant |
2 weeks, 6 weeks, 3 months and 6 months post-surgery |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
01/03/2025 |
| 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
|
Objective:
This open-label randomized comparative study aimed to assess the efficacy and outcomes of two different intramedullary implants, Proximal Femoral Nail (PFN) and PFN-A2, in the surgical management of acute, unstable intertrochanteric femur fractures. Study Design and Setting:
Conducted at All India Institute of Medical Scinces, Nagpur, the study includes patients presenting with hip pain due to trauma, such as Road Traffic Accidents or falls, in the Orthopaedics OPD or Emergency Department. Eligible patients will undergo randomization to receive either PFN or PFN-A2 implants. Methods:
Patients aged 50-80 years with acute, unilateral, closed intertrochanteric femur fractures (AO31A2, AO31A3) and independently ambulatory before the injury will be included. Surgical procedures will be performed under various forms of anesthesia, and outcomes will be evaluated through clinical, radiological assessments, and functional scores (Parker Palmer Mobility Score, Harris Hip Score) at 6-month follow-up. Findings:
Demographic data, surgical parameters (perioperative time, C-arm exposures), and postoperative outcomes (reduction quality, complication rates) will be analyzed. Significance:
This study provides valuable insights into choosing the appropriate implant for treating unstable intertrochanteric femur fractures, aiding orthopedic surgeons in decision-making and optimizing patient outcomes. |