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
|
|
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
|
|
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 |