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CTRI Number  CTRI/2023/06/054113 [Registered on: 19/06/2023] Trial Registered Prospectively
Last Modified On: 16/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate and compare the results of use of platelet rich fibrin in trochanteric fractures of the femur fixed with proximal femoral nail by assessing clinically and radiologically 
Scientific Title of Study   OUTCOME OF TROCHANTERIC FEMUR FRACTURES STABILIZED WITH PROXIMAL FEMORAL NAIL WITH AND WITHOUT PLATELET RICH FIBRIN: A RANDOMIZED CONTROL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  YASH JAIN 
Designation  POST GRADUATE STUDENT 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  ROOM NO 307,OLD RESIDENT DOCTORS HOSTEL,MAMC CAMPUS
NEAR LOK NAYAK HOSPITAL
Central
DELHI
110002
India 
Phone  8299452373  
Fax    
Email  dryashjain20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumit Sural 
Designation  Professor 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  ROOM NO. 605 DEPARTMENT OF ORTHOPAEDICS LOK NAYAK HOSPITAL MAMC CAMPUS
NEAR LOK NAYAK HOSPITAL
Central
DELHI
110002
India 
Phone  9968604323  
Fax    
Email  sumitsural@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  YASH JAIN 
Designation  POST GRADUATE STUDENT 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  ROOM NO.307 OLD RESIDENT DOCTORS HOSTEL,MAMC CAMPUS
NEAR LOK NAYAK HOSPITAL
Central
DELHI
110002
India 
Phone  8299452373  
Fax    
Email  dryashjain20@gmail.com  
 
Source of Monetary or Material Support  
lok nayak hospital,jawaharlal nehru marg,mamc capmus,new delhi,110002 
 
Primary Sponsor  
Name  MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED LOK NAYAK HOSPITAL 
Address  JLN MARG,NEW DELHI,110002 
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 
YASH JAIN  Lok Nayak hospital  Operation theatre block,Lok Nayak Hospital,JLN Marg,110002 CENTRAL DELHI
Central
DELHI 
8299452373

dryashjain20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,Maulana Azad Medical College  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 
Intervention  Liquid Platelet rich fibrin application  1.To assess fracture union with and without use of platelet rich fibrin in trochanteric femur fracture 2.To evaluate the clinical outcome with and without use of platelet rich fibrin in trochanteric femur fracture  
Comparator Agent  RUSH score, harris hip score,vas score  to compare radiological and clinical outcome between two groups(with and without use of platelet rich fibrin in trochanteric femur fracture) 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.All patients with trochanteric femur fracture in the age group 30 - 85 years.
2.All trochanteric fractures surgically stabilized with proximal femoral nail with helical blade.
 
 
ExclusionCriteria 
Details  1.Open trochanteric fractures
2.Pathological trochanteric fractures
3.Platelet count less than 1.2 lakhs.
4.Patient on any medication altering the platelet count or the function.
5.Immunocompromised patient.
6. Any systemic infections which impair normal healing.
7. Metabolic bone disease.
8.Patients of unsound mind or undergoing psychiatric treatment
9.HIV, diabetic, HbsAg positive patients or any patient requiring universal precaution.
10. Patients of stroke, hemiplegia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
PRIMARY: Assessment of radiological union by using RUSH score for trochanteric fractures femur.
 
1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical status will be evaluated by assessing the functional status of patients using Harris hip score & visual analogue scale for pain & any complications related to use of PRF will be recorded.

 
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 2 
Date of First Enrollment (India)   01/07/2023 
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 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  

The present study has been designed as an intervention comparative study to evaluate the effect of platelet rich fibrin in bone union and its clinical outcome when given at site of fracture during internal fixation in trochanteric fractures. Patients with trochanteric fractures of femur are invited to participate in this study. If they are fulfilling the inclusion criteria they will undergo a standardized history and physical examination by clinicians.All the eligible patients will be divided in two groups after randomisation and allocation with the help of computer and sequential sealed envelope method. After randomisation two groups(Group N and Group PRF) will be created. If they are in the PRF group then they will receive PRF injection along with standard treatment. Written informed consent will be taken from all patients partcipating in the study and additional consent for PRF injection will be taken from patients in  Group PRF. During the surgery, 20 ml of blood will be taken from patient which might cause some discomfort due to needle prick and which will be used to make platelet rich fibrin using a centrifuge, This PRF will be injected to fracture site.  Patient will be assessed postoperatively clinically using Visual analogue scale and Harris Hip Score and radiologically using RUSH Score. If you are willing to participate in the study then you have to undergo a follow up of atleast 6 months which include 4 visits. At  each follow up you will be assessed clinically and radiologically.X rays will be done at 2 weeks, 6 weeks, 3 months, and if necessary at 6months

 
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