| CTRI Number |
CTRI/2025/03/081549 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing different types of fracture fixation methods in extraarticular fractures of distal femur |
|
Scientific Title of Study
|
Comparing Locking compression plating and Retrograde intramedullary nailing in the treatment of extraarticular fractures of the distal femur: A Randomised controlled study |
| 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 Rohit Raj R |
| Designation |
Orthopaedic resident |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics,
SRM medical college hospital and research center,
Kattankulathur,
Chengalpattu district
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8870022123 |
| Fax |
|
| Email |
rohitraj312000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Kumar Naidu. E |
| Designation |
Professor |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics,
SRM medical college hospital and research center,
Kattankulathur,
Chengalpattu district
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884460536 |
| Fax |
|
| Email |
erraguntladilipnaidu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Raj R |
| Designation |
Orthopaedic resident |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics,
SRM medical college hospital and research center,
Kattankulathur,
Chengalpattu district
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8870022123 |
| Fax |
|
| Email |
rohitraj312000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics,
SRM medical college hospital and research center,
Kattankulathur,
Chengalpattu district,
Tamilnadu,India,
Pincode- 603203 |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Raj R |
| Address |
Department of Orthopaedics,
SRM medical college hospital and research center,
Kattankulathur,
Chengalpattu district,Tamilnadu 603203 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rohit Raj R |
SRM medical college hospital and research center |
Department of Orthopaedics,
SRM medical college hospital and research center,
Kattankulathur,
Chengalpattu district, Tamilnadu 603203
Kancheepuram
TAMIL NADU |
8870022123
rohitraj312000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S724||Fracture of lower end of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Locking compression plating of distal femur |
LCP offers anatomical fixation and has been used since long for fixation of these fractures. |
| Comparator Agent |
Retrograde intramedullary nailing of femur |
Retrograde IMIL nail has a mechanical advantage of an intramedullary device that is close to the axis of the femur and has biological advantage of minimal disruption of blood supply
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Extra articular distal femur fractures ( AO type A1,A2,A3)
-Gustilo Anderson classification grade I and grade II |
|
| ExclusionCriteria |
| Details |
-Gustilo Anderson classification grade III
- Distal femur fracture AO type B and C
- Associated vascular injury
- Periprosthetic fracture
- Pathological fracture |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Surgical outcome- Surgical duration and blood loss
Functional outcome - VAS, SANDERS scale, LYSHOLM knee score. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional outcome - VAS, SANDERS scale, LYSHOLM KNEE score
Radiological outcome |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/03/2025 |
| 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
|
The two surgical techniques which are commonly used are extra medullary fixation with an anatomical locking compression plate (LCP) or intramedullary fixation with retrograde nail
LCP offers anatomical fixation and has been used since long for fixation of these fractures. But open reduction hampers the natural process of fracture healing and is associated with higher rates of infection and non union
Retrograde IMIL nail has a mechanical advantage of an intramedullary device that is close to the axis of the femur and has biological advantage of minimal disruption of blood supply
Several studies have compared the outcomes between the two surgical techniques and showed that IMIL nailing is better than LCP in terms of infection rates and also IMIL nailing causes stimulation of blood supply aided by reaming. The need for the study is to evaluate the differences in clinical, surgical and radiological outcomes between the 2 surgical techniques.
|