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CTRI Number  CTRI/2026/01/102119 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing InterTAN nail and proximal femoral nail surgery in adults with intertrochanteric hip fractures to assess functional recovery and healing in x ray. 
Scientific Title of Study   Randomized Controlled Trial of InterTAN Nail Versus Conventional Proximal Femoral Nail: Comparative Analysis of Functional and Radiological Outcomes in Intertrochanteric Femur Fractures 
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 Bidyut Jyoti Bora 
Designation  Post Graduate Student 
Affiliation  AIIMS Guwahati, Assam, India 
Address  Department of Orthopaedics, AIIMS Guwahati, Assam, 781101, India
NIL
Kamrup
ASSAM
781101
India 
Phone  9954638520  
Fax    
Email  bidyutjyoti.987@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sharan Mallya P 
Designation  Associate Professor 
Affiliation  AIIMS Guwahati, Assam, India 
Address  AIIMS Guwahati, Department of Orthopaedics.

Kamrup
ASSAM
781101
India 
Phone  9901771260  
Fax    
Email  sharanmallya@aiimsguwahati.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sharan Mallya P 
Designation  Associate Professor 
Affiliation  AIIMS Guwahati, Assam, INDIA 
Address  AIIMS Guwahati, Department Of Orthopaedics

Kamrup
ASSAM
781101
India 
Phone  9901771260  
Fax    
Email  sharanmallya@aiimsguwahati.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Guwahati 
Address  AIIMS GUWAHATI, ASSAM ,INDIA ,781101 
Type of Sponsor  Research institution 
 
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 Sharan Mallya P  All India Institute of Medical Sciences, Guwahati  Department of Orthopaedics, OPD, room no 21
Kamrup
ASSAM 
09901771260

sharanmallya@aiimsguwahati.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE,AIIMS GUWAHATI  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  Conventional Proximal Femoral Nail  Patients with intertrochanteric femur fractures will undergo surgical fixation using conventional proximal femoral nail as per standard operative protocol. Surgery will be performed under spinal or general anesthesia by experienced orthopedic surgeons. Postoperative rehabilitation will follow institutional protocol 
Intervention  InterTAN Nail  Patients with intertrochanteric femur fractures will undergo surgical fixation using InterTAN intramedullary nail as per standard operative protocol. Surgery will be performed under spinal or general anesthesia by experienced orthopedic surgeons. Postoperative rehabilitation will follow institutional protocol. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Clinico-radiological diagnosis of intertrochanteric femur fracture..
2. Age more than eighteen years 
 
ExclusionCriteria 
Details  1. Open fractures.
2. Pathological fractures.
3. Multiple fractures.
4. History of previous surgery in the lower limb.
5. Patients with cognitive disorders. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Functional outcome assessment using Harris Hip Score   six months post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
operating time in minute  Intraoperative 
Blood loss in mL  Introperative 
Surgical site infection   postoperative 
Radiation exposure during the procedure in terms of number of C-arm shots  Intraoperative 
Fracture union, Neck-shaft angle changes, screw-cut out, Z-effect and Varus collapse.  Three and Six months postoperatively 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   10/02/2026 
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="2"
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  
This study is a single center randomized controlled trial conducted in the Department of Orthopaedics at All India Institute of Medical Sciences Guwahati. The study aims to compare the functional and radiological outcomes of InterTAN nail versus conventional proximal femoral nail in the surgical management of intertrochanteric femur fractures.
Patients aged more than 18 years with clinico radiological diagnosis of intertrochanteric femur fracture will be included after obtaining written informed consent. Patients with open fractures pathological fractures multiple fractures previous surgery in the same limb or cognitive disorders will be excluded. Eligible patients will be randomized into two groups using computer generated random allocation. One group will undergo fixation with InterTAN nail and the other group will be treated with conventional proximal femoral nail.
All surgeries will be performed under standard aseptic precautions by experienced orthopaedic surgeons. Postoperative management will be similar in both groups including antibiotics thromboprophylaxis and early mobilization. Patients will be followed up at two weeks three months and six months after surgery.
The primary outcome will be functional outcome assessed using the Harris Hip Score at six months postoperatively. Secondary outcomes will include radiological assessment of fracture union and neck shaft angle and evaluation of perioperative and postoperative complications such as screw cut out, varus collapse and implant related complications. The results of this study will help determine the comparative effectiveness and safety of InterTAN nail and conventional proximal femoral nail in intertrochanteric femur fractures.
 
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