| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Patna - Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507 |
| Type of Sponsor |
Government medical college |
|
|
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 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
|
|
|
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. |