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CTRI Number  CTRI/2025/03/082370 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Femur Nailing in Lateral versus Supine Position  
Scientific Title of Study   Surgical Efficiency and Outcomes of Femur Nailing in Lateral versus Supine Position - A Randomized Controlled 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  Dr Saket Prakash 
Designation  Assistant Professor 
Affiliation  AIIMS Patna 
Address  Department of Trauma Surgery and Critical care, Room No.- 105, First floor Trauma Block, AIIMS Patna-801507
Department of Trauma Surgery and Critical care, Room No.- 105, First floor Trauma Block, AIIMS Patna-801507
Patna
BIHAR
801507
India 
Phone  09681697509  
Fax    
Email  drsaket007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saket Prakash 
Designation  Assistant Professor 
Affiliation  AIIMS Patna 
Address  Department of Trauma Surgery and Critical care, Room No.- 105, First floor Trauma Block, AIIMS Patna-801507
Department of Trauma Surgery and Critical care, Room No.- 105, First floor Trauma Block, AIIMS Patna-801507
Patna
BIHAR
801507
India 
Phone  09681697509  
Fax    
Email  drsaket007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saket Prakash 
Designation  Assistant Professor 
Affiliation  AIIMS Patna 
Address  Department of Trauma Surgery and Critical care, Room No.- 105, First floor Trauma Block, AIIMS Patna-801507
Department of Trauma Surgery and Critical care, Room No.- 105, First floor Trauma Block, AIIMS Patna-801507
Patna
BIHAR
801507
India 
Phone  09681697509  
Fax    
Email  drsaket007@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  Patna - Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507 
Type of Sponsor  Government 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 Saket Prakash  AIIMS Patna  Department of Trauma Surgery and Critical care, Room No.- 105, First floor Trauma Block, AIIMS Patna-801507
Patna
BIHAR 
9654857098

drsaket007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Patna Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S723||Fracture of shaft of femur, (2) ICD-10 Condition: S722||Subtrochanteric fracture of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lateral position  femur Nailing In lateral position will be compared with femur nailing in supine position for 18 months 
Comparator Agent  Supine Position  femur Nailing In lateral position will be compared with femur nailing in supine position for 18 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with femur fractures requiring nailing.
2. Age [18-60 years].
3. Fit for general/spinal anaesthesia
 
 
ExclusionCriteria 
Details  1. Open fractures.
2. Patients with comorbidities/conditions impacting surgery.
3. Previous femur surgeries.
4. Intertrochanteric femur fracture
5. Polytrauma
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
This study aims to assess a broader spectrum of outcomes, including surgical

efficiency ( setup time, operative time), intraoperative imaging quality, surgeon ergonomics.  
Baseline
At 4 Weeks, 8 Weeks, 12 Weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
patient-centric outcomes ( functional recovery, complication rates).  Baseline
At 4 Weeks, 8 Weeks, 12 Weeks 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   01/04/2025 
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 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  

Femoral shaft fractures are among the most common long bone fractures, often occurring most frequently in young males after high-energy trauma such as motor vehicle accidents and in elderly females after falls from standing. Incidences of such fractures have been found to be increased due to increasing population and use of motor vehicles. The majority of adult femur fractures are treated surgically with intramedullary nailing regarded as the gold standard treatment for management. Despite its widespread use, the success of femoral nailing procedures is influenced by several factors, including the patient’s positioning during surgery.

Two primary positions are commonly employed during femoral nailing: the lateral decubitus position and the supine position. Each position has its advantages and disadvantages. The supine position is favoured for familiarity among surgical teams. Conversely, the lateral position is preferred by some surgeons for its potential benefits in specific fracture patterns, such as proximal or distal femur fractures, due to improved mechanical alignment and access. In the lateral decubitus position, finding the trochanteric entry site, ensuring reduction, and placing the apical and distal locking screws can be done more easily and quickly. Lateral positioning is preferred in sub-trochanteric femur fracture and in obese patients for the ease of reduction and making entry. Since it can be done on simple OT table, hence cost effective and can be done at any centre where they lack fracture table.

 
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