| CTRI Number |
CTRI/2025/03/081560 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The Effect of Intra Articular Platelet Rich Plasma Injection in Knee Osteoarthritis |
|
Scientific Title of Study
|
The Effect of Intra Articular Platelet Rich Plasma Injection in Knee Osteoarthritis |
| 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 Amit Saraf |
| Designation |
Professor & Head |
| Affiliation |
|
| Address |
Department of Orthopaedics Teerthanker Mahaveer Medical College and Research Centre, NH 24 Delhi Road
Moradabad Uttar Pradesh 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9780029750 |
| Fax |
|
| Email |
amitsaraf_75@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Saraf |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Orthopaedics Teerthanker Mahaveer Medical College and Research Centre, NH 24 Delhi Road
Moradabad Uttar Pradesh 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9780029750 |
| Fax |
|
| Email |
amitsaraf_75@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Saraf |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Orthopaedics Teerthanker Mahaveer Medical College and Research Centre, NH 24 Delhi Road
Moradabad Uttar Pradesh 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9780029750 |
| Fax |
|
| Email |
amitsaraf_75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre, Moradabad 244001 , Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre
NH 24 , Delhi Road , Moradabad 244001, Uttar Pradesh |
| Type of Sponsor |
Private 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 Mayank Phogaat |
Teerthanker Mahaveer Medical College and Research Centre |
Department of Orthopaedic
Teerthanker Mahaveer Medical College and Research Centre, NH24 Delhi Road, Bagadpur , Moradabad
UTTAR PRADESH
Moradabad
UTTAR PRADESH |
9999338066
mayankphogaat11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 - intra articular injection of platelet rich plasma |
Patients will be recruited from the OPD after applying ACR criteria & KL Grade Il and Ill on X-RAY KNEE AP/LAT (STANDING) and applying inclusion and exclusion criteria . Randomisation will be done via a computer-generated random sequence. VAS, WOMAC, Serum Coll2-1 NO2 (VAS, WORMS will be taken Before Ist PRP Intraarticular injection. Then USG-guided Ist Intraarticular injection of PRP will be given.
After I month VAS, WOMAC will be taken and USG-guided 2nd PRP Intraarticular injection will be given. After 6 month VAS, WOMAC will be taken. VAS, WOMAC, Ser. Coll2-INO2, X-Ray, MRI study (WORMS) will be taken after 9 months to study the effect. |
| Comparator Agent |
Group 2 - Intraarticular Injection of Normal Saline |
Patients will be recruited from the OPD after applying ACR criteria & KL Grade Il and Ill on X-RAY KNEE AP/LAT (STANDING) and applying inclusion and exclusion criteria . Randomisation will be done via a computer-generated random sequence. VAS, WOMAC, Serum Coll2-1 NO2 (VAS, WORMS will be taken Before Ist Normal Saline Intraarticular injection. Then USG-guided Ist Intraarticular injection of Normal Saline will be given.
After I month VAS, WOMAC will be taken and USG-guided 2nd Normal Saline Intraarticular injection will be given. After 6 month VAS, WOMAC will be taken. VAS, WOMAC, Ser. Coll2-INO2, X-Ray, MRI study (WORMS) will be taken after 9 months to study the effect. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients over 18 years of age who had been diagnosed with osteoarthritis of the knee according to the American College of Rheumatology (ACR) 2019 criteria were included in this study.
2) Among these patients, only those diagnosed with Grade II and Grade III osteoarthritis of the knee joint, as classified by the Kellgren-Lawrence scale |
|
| ExclusionCriteria |
| Details |
a. Any known malignancy.
b. Gouty Arthritis /inflammatory arthritis, Secondary Osteoarthritis
c. Active knee infection.
d. Disorders of Bleeding
e. Uncontrolled Diabetes Mellitus
f. Ligamentous instability of knee (MRI DIAGNOSED)
g. Contraindication to MRI
h. Any history of previous intraarticular steroid injection. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare the functional outcome in patients of Knee Osteoarthritis before each PRP/NS
Injection and at 6 months and at 9 months and study their effect.
2.To assess and compare the Radiological outcome with the help of WORMS score and X-Ray in patients of Knee Ostenarthritis and observe the chances at the end of 9 months. |
1,2,6 and 9 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the change in biomarker of cartilage degeneration (serum Coll2-1No2)(8) values after IA PRP injection & IA NS injection with the clinical improvement seen after the intervention. |
9 months |
| To compare the articular cartilage changes on specialized MRI sequences(WORMS)(9) before and after the intervention |
Before intervention and after 9 month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
11/03/2025 |
| 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="6"
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
|
Patients will be recruited from the OPD after applying ACR criteria & KL Grade II and III on X-RAY KNEE AP/LAT (STANDING) and applying inclusion and exclusion criteria;. Randomization will be done via a computer-generated random sequence and patient will be divided into 2 groups (Group A-PRP; Group B-NS) VAS, WOMAC, Ser. Coll2-1NO2, X-Ray, MRI study {WORMS} Before 1stPRP/NS(Baseline) Intraarticular injection Then USG-guided 1st Intraarticular injection of GFC/NS will be given After 1 month VAS, WOMAC will be taken and USG-guided 2nd PRP/NS Intraarticular injection will be given After 6 month VAS, WOMAC will be taken VAS, WOMAC, Ser. Coll2-1NO2, X-Ray, MRI study (WORMS) will be taken after 9 months to study the effect |