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CTRI Number  CTRI/2025/03/083182 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 24/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two types of surgeries in patients undergoing treatment for broken thigh bone. 
Scientific Title of Study   Comparison of Surgical, Functional and Radiological Outcomes following Integrated Screw and Nail System (ISNS)Versus Helical-Blade Anti- rotation Proximal Femoral Nail (PFNA2) in Trochantreic fractures - a Randomised Control Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samuel Kirubakaran 
Designation  Post Graduate 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Dept of Orthopaedics, PIMS, Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9444435842  
Fax    
Email  samdkiru@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Naveen Sake 
Designation  Associate professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Dept of Orthopaedics, PIMS, Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9949550202  
Fax    
Email  naveen.sake@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Samuel Kirubakaran 
Designation  Post Graduate 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Dept of Orthopaedics, PIMS, Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9444435842  
Fax    
Email  samdkiru@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical sciences, Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry, Country - India, Pincode - 605014  
 
Primary Sponsor  
Name  Pondicherry Institute of Medical science 
Address  PIMS, Kalapet, Puducherry - 605014 
Type of Sponsor  Private medical college 
 
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 Samuel Kirubakaran D  Pondicherry Institute of Medical Science  Department of Orthopaedics, No-101, PIMS, Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY 
9444435842

samdkiru@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S721||Pertrochanteric fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Helical Blade (PFNA2)  It is impacted around the cancellous bone by compaction anchored in the femoral head which provides rotational and angular stability. 
Intervention  Integrated Screw and Nail System (ISNS)  It is a type of fixation , in which two cephalo-cervical screws that provide linear compression and additional resistance to the rotation of the femoral head. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All cases of isolated unilateral intertrochanteric femur fractures
2. Age more than18 years,
3. Patients consented to participate are included in the study. 
 
ExclusionCriteria 
Details  1. All open injuries and Pathological fractures
2. Patients refused to participate in this program,
3. Patients with associated injuries (such as head injury, abdominal injury, or other bone injuries),
4. Patients with a subtrochanteric femur fracture,
5. Patients with a intra-capsular femur fracture. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Operative time in minutes ,
Blood loss (ml) ,
Number of C-Arm shots 
base line - during the day of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Cut through, DVT, embolism , femoral neck angle, Hip apex angle, neck shaft angle, ROM, knee pain/ stiffness, Weight bearing, Modified harris hip score, Katz index  2 weeks, 6 weeks, 12 weeks, 18 weeks & 24 weeks after surgery 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   04/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  04/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 fractures are one of the most prevalent orthopaedic injuries as more than a million human subjects are prone for the same. Nearly half of all hip fractures are intertrochanteric femur fractures (IFFs), which are more common among the elderly and are often as a result of low-energy traumas. In order to achieve a satisfactory early recovery of the injured patients, surgical treatment is mandatory to manage these fractures. The gold standard therapy for stable intertrochanteric fractures, was earlier the dynamic hip screw (DHS) implant. However, they were found inadequate for the stabilizing fractures of the unstable kind. Contrarily, as opposed to extramedullary devices such as DHS, proximal femoral nails (PFN) have a biomechanical advantage because of their closer location to the vector of force as opposed to extramedullary devices, and shorter moment arm. Moreover, based on the results of several earlier reports, intramedullary fixation may be preferable to extramedullary fixation for hip fracture patients as the functional scores are higher and there is a lower risk of implant failure and reoperation. Further, only a minimally invasive procedure is required to implant a PFN. Therefore, a closed reduction of the fracture, aids to maintain the haematoma, and the surgeon can perform a minimally invasive procedure with least possible soft-tissue dissection, thereby lowering surgical trauma, blood loss, infection, and wound complications.

Healing of the bones is significantly managed by the interfragmentary linear compression provided by the lag screw in majority of the PFNs. One or two lag screws, integrated or locked lag screws, and a wedge block that offers rotational stability are some of the PFN designs available in the market. Clinical and radiological evaluations of only two distinct PFNs have been studied extensively. However, only few studies have compared the differences between ISNS and PFNA2 with respect to its surgical outcome, and radiological outcome in patients treated with closed reduction and internal fixation for IFFs and this study aims to bring in more light in this area.

 
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