| CTRI Number |
CTRI/2025/02/079931 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison Of Effect Of Intraarticular Growth Factor Concentrate Injection And Intraarticular Normal Saline Injection in Knee Osteoarthritis. |
|
Scientific Title of Study
|
The Effect Of Intraarticular Growth Factor Concentrate 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 |
| Affiliation |
Teerthankar Mahaveer Medical College and Research Centre |
| Address |
Department of Orthopaedics, Teerthankar Mahaveer Medical college and research centre, NH24 Delhi road, Moradabad
Moradabad
UTTAR PRADESH
244001
India
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 |
Teerthankar Mahaveer Medical College and Research Centre |
| Address |
Department of Orthopaedics, Teerthankar Mahaveer Medical college and research centre, NH24 Delhi road, Moradabad
Moradabad
UTTAR PRADESH
244001
India
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 |
Teerthankar Mahaveer Medical College and Research Centre |
| Address |
Department of Orthopaedics, Teerthankar Mahaveer Medical college and research centre, NH24 Delhi road, Moradabad
Moradabad
UTTAR PRADESH
244001
India
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, Delhi road,Moradabad 244001 ,
Uttar Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Teerthankar Mahaveer Medical College and Research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre,
N.H.-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 Sahil Shah |
Teerthankar MahaveerMedical college and research centre |
Room no - 407, Department of Orthopaedics, Teerthankar Mahaveer
Medical College and
Research Centre, NH24
Delhi Road, Bagadpur,
Moradabad,Moradabad
Moradabad
UTTAR PRADESH
Moradabad
UTTAR PRADESH |
9879476883
sahilbshah711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthankar Mahaveer University- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraarticular Injection of Growth Factor Concentrate |
Patients will be recruited from the OPD after applying ACR criteria & KL
Grade Il and III on X-RAY KNEE AP/LAT (STANDING) and applying inclusion and exclusion criteria. After which Baseline VAS, WOMAC, Ser. Coll2-1NO2, X-Ray, MRI study {WORMS} wiil be done then USG-guided 1st Intraarticular injection of Growth Factor Concentrate will be given. After 1 month VAS, WOMAC will be taken and USG-guided 2nd Intraarticular injection of Growth Factor Concentrate will be given. After 6 month VAS, WOMAC will be taken and VAS, WOMAC, Ser. Coll2-1N02, X-Ray, MRI study {WORMS} will be taken after 9 months to study the effect. |
| Comparator Agent |
Intraarticular Injection of Normal Saline |
Patients will be recruited from the OPD after applying ACR criteria & KL Grade Il and III on X-RAY KNEE AP/LAT (STANDING) and applying inclusion and exclusion criteria. After which Baseline VAS, WOMAC, Ser. Coll2-1NO2, X-Ray, MRI study {WORMS} wiil be done then USG-guided 1st Intraarticular injection of Normal Saline will be given. After 1 month VAS, WOMAC will be taken and USG-guided 2nd Intraarticular injection of Normal Saline will be given. After 6 month VAS, WOMAC will be taken and VAS, WOMAC, Ser. Coll2-1N02, 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 |
Patient of either age group Diagnosed with Osteoarthritis Knee as per American College of Rheumatology (ACR) 2019 criteria. Among the above patients who are diagnosed with Grade II and III Osteoarthritis of the knee joint according to the Kellgren-Lawrence scale are selected. |
|
| ExclusionCriteria |
| Details |
1.Any known malignancy
2.Gouty Arthritis /inflammatory arthritis, Secondary Osteoarthritis
3.Active knee infection.
4.Disorders of Bleeding
5.Uncontrolled Diabetes Mellitus
6.Ligamentous instability of knee (MRI DIAGNOSED)Â
7.Contraindication to MRI
8.Any history of previous intraarticular steroid injection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the functional outcome in patients of Knee Osteoarthritis before each GFC/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 Osteoarthritis and observe the changes at the end of 9 months. |
1,2,6 and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To assess and compare the cartilage degeneration with the help of Biochemical marker Serum Coll2-1NO2 levels at the final follow-up and compared to the baseline serum levels to analyse the effects of both GFC and NS on its level in the body. |
1,2,6 and 9 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
15/02/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
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-GFC; Group B-NS)
VAS, WOMAC, Ser. Coll2-1NO2, X-Ray, MRI study{WORMS} Before 1stGFC/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 GFC/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
|