| CTRI Number |
CTRI/2024/03/063715 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of platelet rich plasma in treatment of knee osteoarthritis:A single group pre & post intervention study |
|
Scientific Title of Study
|
Efficacy of Platelet Rich Plasma in treatment of knee osteoarthritis: A single group Pre & Post intervention QUASI Experimental 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 Veena Mathur |
| Designation |
HOD and Senior Professor |
| Affiliation |
JLN Medical College Ajmer |
| Address |
Department of Anaesthesia new OT 1st floor Jawahar Lal Nehru Medical College and Hospital Kalabagh
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Mathur |
| Designation |
HOD and Senior Professor |
| Affiliation |
JLN Medical College Ajmer |
| Address |
Department of Anaesthesia New OT 1st floor Jawahar Lal Nehru Medical College and Hospital
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Mathur |
| Designation |
HOD and Senior Professor |
| Affiliation |
JLN Medical College Ajmer |
| Address |
Department of Anaesthesia New OT 1st floor Jawahar Lal Nehru Medical College and Hospital
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawahar Lal Nehru Medical College and Hospital Kalabagh Ajmer |
|
|
Primary Sponsor
|
| Name |
JLN Medical College |
| Address |
JLN Medical College Ajmer Rajasthan |
| 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 MADAN LAL ROJ |
Jawahar Lal Nehru Medical College |
Department of Anaesthsia New OT 1t floor Jawahar Lal Nehru Medical College and Hospital, Ajmer
Ajmer
RAJASTHAN |
9887089528
mail.drmadanlal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Jawahar Lal Nehru Medical College and Hospital Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Platelet rich plasma |
Under all aseptic precautions PRP will be prepared by taking 22 ml venous
blood in single use PRP kit and single spin method at 3500 RPM for 15 minutes. Under aseptic conditions,
ultrasound guided Intraarticular injection through the suprapatellar approach 8 mL of platelet concentrate will be injected into a suprapatellar pouch through a supero lateral approach with an 22-gauge needle. The knees were immobilized for 10 min after injection |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 45-65 years with either side OA knees (ASA class I and II) of either gender
History of pain in last month
Those with imaging findings (X-ray) of degenerative changes of the joint without significant deformity (diagnosed by KL classification ( Grade 2 and 3) |
|
| ExclusionCriteria |
| Details |
Patients with KL grading I ( doubtful disease) and grade 4 (Severe disease)
Patient with history of diabetes mellitus
On Immunosuppressive drugs
Collagen vascular disorders
Cancer or malignant disorders
Active infection/ wound of knee
Patients with autoimmune and platelet disorders
Treatment with anticoagulant and antiplatelet medications within 10 days before injection
Use of NSAIDs within 2 days before injection or unwilling to stop then post injection except paracetamol
History of knee articular injection of corticosteroid during previous 3 months or use of systemic corticosteroids 2 weeks before PRP injection
Patients with genu valgum/Varum greater than 20 degrees
Human immunocompromised virus, Hepatitis B virus, Hepatitis C virus, venereal Disease Research Laboratory virus positive cases
Knee surgery on affected side within last 12 months
Systemic or inflammatory knee disease
Presence of warm and tense joint effusion
High chances of loss of follow-up
History of trauma to affected knee
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain will be assessed by WOMEC score and Visual Analogue Score |
Patients will be evaluated
on 6 week, 3 months and 6 months after the first injection by a blinded observer
for change in WOMAC score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS score |
at baseline/ 6 week / 3 month and 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/03/2024 |
| 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="0"
Months="6"
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
|
80 participants who will meet the inclusion criteria and giving informed
written consent will be evaluated for their WOMAC score and radiological
grading of knee joint. Under all aseptic precautions PRP will be prepared by taking 22 ml venous
blood in single use PRP kit (PrecureCellTM) and single spin method at 3500 RPM
for 15 minutes. PRP will be injected immediately after preparation to prevent any
contamination. Under aseptic conditions,
ultrasound guided Intraarticular injection through the suprapatellar approach 8
mL of platelet concentrate will be injected into a suprapatellar pouch through a
supero lateral approach with an 22-gauge needle. The knees were immobilized
for 10 min after injection. Data will be collected including baseline WOMAC
score (Western Ontario and McMaster Universities Osteoarthritis Index) by an
independent observer in each knee. Patient will be lied down in supine position for 2 h and monitored for HR,
BP, SPO2 and any adverse events. Patients will be evaluated
on 6 week, 3 months and 6 months after the first injection by a blinded observer
for change in WOMAC score. Data will be collected and analysed using standard tests and p value of less than 0.05 will be considered significant |