| 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
|
|
|
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
|
|
|
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
|
|
|
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. |