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CTRI Number  CTRI/2025/07/090235 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On: 27/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing short and long implants used to treat hip fractures in elderly patients due to trivial trauma. 
Scientific Title of Study   short versus long proximal femoral nails in unstable intertrochanteric femur fractures: a comparision of postoperative 30- day mortality, associated factors and functional outcomes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasoon Kumar 
Designation  Assitant Professor 
Affiliation  PGIMER, Chandigarh 
Address  #15, Nehru Hospital Depatment of Orthopedics, PGIMER, Chandigarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  9781002142  
Fax    
Email  drprasoonksingh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasoon Kumar 
Designation  Assitant Professor 
Affiliation  PGIMER, Chandigarh 
Address  #15, Nehru Hospital Depatment of Orthopedics, PGIMER, Chandigarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  9781002142  
Fax    
Email  drprasoonksingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasoon Kumar 
Designation  Assitant Professor 
Affiliation  PGIMER, Chandigarh 
Address  #15, Nehru Hospital Depatment of Orthopedics, PGIMER, Chandigarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  9781002142  
Fax    
Email  drprasoonksingh@gmail.com  
 
Source of Monetary or Material Support  
Institute Ethics Committee,Research Block B, PGIMER, Chandigarh,India 160012 
 
Primary Sponsor  
Name  PGIMER CHANDIGARH 
Address  Research Grant Cell, Research Block A,PGIMER Chandigarh, India 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasoon Kumar  Postgraduate Institute of Medical Education and Research   22 OT, 2nd floor, b block, Nehru Hospital
Chandigarh
CHANDIGARH 
9781002142

drprasoonksingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M97||Periprosthetic fracture around internal prosthetic joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  long nail group  other half of patients will end up in long nail group based on the length of nail put in patient [300 mm - 420 mm] 
Intervention  short nail group   half of the patients will end up in short nail group based on the length of nail put in the patient [180 - 240 mm ] 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Cases of isolated unstable intertrochanteric femur fractures
2.Age more than 50 years
3.Trivial trauma
4.Surgery within 72 hours of injury 
 
ExclusionCriteria 
Details  1. Stable fractures
2. Pathological fractures
3. High energy trauma or polytrauma
4. Immunocompromised patients
5. Local infection
6. Acute MI and Stroke within 1 month
7. Hemiplegic
8. Patient height Less than 5 feet
9. Refuses participation
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare outcomes associated with short and long proximal femur nail anti-rotation in the treatment of unstable inter-trochanteric femur fractures in the elderly and assess factors impacting them.   30 days 
 
Secondary Outcome  
Outcome  TimePoints 
A. Duration of surgery: measured from skin incision to closure
B. Measurement of surgical APGAR score intraoperatively
C. Measurement of presence or absence of delirium preoperatively and
postoperatively using Confusion assessment method (CAM)
D. Duration of hospital stay; measured from date of admission to discharge
E. Functional outcome using MHHS scoring
F. Mortality by post operative day 90 
90 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/08/2025 
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="6"
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  

Osteoporotic hip fractures in elderly populations are a growing concern worldwide with increasing life expectancy and growing elderly population; these fractures include fractures of the neck of femur and femoral head, intertrochanteric and subtrochanteric femur fractures. Gullberg et al.in 1997 estimated that the incidence of hip fractures worldwide could be upto 2.6 million by the year 2025 and 4.5 million by the year 2050.

The intertrochanteric region of femur is located between the greater and lesser trochanters and is composed of dense trabecular bone; these fractures are extracapsular fractures of the proximal femur between the trochanters. These fractures have bimodal age distribution with both the young and the elderly affected; however on one hand high energy trauma is the mode of injury in the young, in the elderly population low energy trivial trauma compounded by osteoporosis is the associated mechanism. Patients most commonly present with a history of pain and inability to ambulate after a fall or other injury. The pain is located at the proximal thigh and is exacerbated by passive or active attempts of hip flexion or rotation. The physical findings are shortening and external rotation of the extremity.

As far as the nail designs go, both short and long lengths of the nail are available and there are different types of proximal locks like double screws, spiral blade and single compression screw configurations.

Long nails are available with lengths from 260 to 460 mm and short nails from 180 to 200 mm. Long nails potentially avoid stress concentration near the distal end, reducing chances of secondary fractures of the shaft. However, recent studies suggest similar results and deem short nails as safe in terms of failure and re-fractures with added advantage of shorter operative time and lesser blood loss compared to long nails.Surgeries with short nails are faster owing to no requirement of reaming and distal locking can be done with zig itself without need of patient positioning and C-arm.  Without reaming, there is additional benefit of lesser chances of intra-operative fat embolism, which can have a critical impact on patient survival post operatively.

However, with the limited number of randomized trials on the comparison, the superiority of one design over the other has been a matter of debate. Several studies have reported positive outcomes with both short and long PFNs for intertrochanteric femur fractures; however, conflicting issues remain regarding the superiority of 1over the other. This present study is conceptualised to address this specific question in terms of intra operative parameters like surgical duration, blood loss, surgical APGAR score; post operative parameters like blood transfusions, Confusion Assessment Method (CAM) score, duration of hospital stay, union rates, re-fractures, functional outcomes (MHHS) and 30 day and 90 day mortality rates. Furthermore, preoperative and intra operative factors will be correlated with the post operative outcomes.

 

In the elderly these fractures present a complex scenario because of co-existent one or multiple co-morbidities and overall frailty; they optimally require early surgery and immediate mobilization to minimize the complications associated with recumbency like decubitus ulcers, decreased cardiopulmonary reserves and thromboembolic events, which could be devastating for these old age patients.

The IT femur fractures are either stable or unstable with the latter described as fractures with either loss of the medialcalcar, or comminuted lateral wall; reverse oblique configuration of the fracture line also makes the fractures unstable. In terms of implant of choice for internal fixation, the adequacy of dynamic hip screw which has been in vogue for stable fractures, is relatively inferior in the unstable intertrochanteric femur fracture, in comparison to proximal femoral nails. In terms of surgical options for the unstable variety, the choice ranges from internal fixation with proximal femoral nails to hip replacements surgeries; the former has been shown to be superior in respect of ambulation and mortality rates.

 
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