CTRI

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CTRI Number

CTRI/2026/03/105105 [Registered on: 02/03/2026] Trial Registered Prospectively

Last Modified On:

01/03/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Biological

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

Effect Of Platelet Rich Plasma Injection In Patients With Early And Moderate Knee Arthritis.

Scientific Title of Study

Efficacy Of Platelet Rich Plasma (PRP) In Kellgren And Lawrence Grades 2-3 Osteoarthritis Of Knee Joint In Patients Attending a Tertiary Care Hospital In Kolkata.

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 Yatharth Ranjan
Designation	Junior Resident
Affiliation	RG Kar Medical College And Hospital
Address	Department Of Orthopaedics, RG Kar Medical College And Hospital,1-Khudiram Bose Sarani, Kolkata Kolkata WEST BENGAL 700004 India
Phone	8825260559
Fax
Email	yatharthranjansinha@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Dr Sanjay Kumar
Designation	Professor and Head
Affiliation	RG Kar Medical College And Hospital
Address	Department Of Orthopaedic, RG Kar Medical College And Hospital,1-Khudiram Bose Sarani, Kolkata Kolkata WEST BENGAL 700004 India
Phone	9163846467
Fax
Email	sanjayorth@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr Yatharth Ranjan
Designation	Junior Resident
Affiliation	RG Kar Medical College And Hospital
Address	Department Of Orthopaedic, RG Kar Medical College And Hospital,1-Khudiram Bose Sarani, Kolkata Kolkata WEST BENGAL 700004 India
Phone	8825260559
Fax
Email	yatharthranjansinha@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	RG Kar Medical College And Hospital
Address	1-Khudiram Bose Sarani, Kolkata 700004
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
PROF Dr SANJAY KUMAR	PROFESSOR AND HEAD, DEPARTMENT OF ORTHOPAEDICS, RG KAR MEDICAL COLLEGE AND HOSPITAL,1-KHUDIRAM BOSE SARANI KOLKATA 700004

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Yatharth Ranjan	RG Kar Medical College And Hospital	Department Of Orthopaedics,1-Khudiram Bose Sarani, Kolkata 700004 Kolkata WEST BENGAL	8825260559 yatharthranjansinha@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institution Ethics Committee, R G Kar Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M171\|\|Unilateral primary osteoarthritisof knee,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Not Applicable	Not Applicable
Intervention	Platelet Rich Plasma (PRP) In Knee Osteoarthritis	Functional Analysis After Giving Injection Prp In Kellgren And Lawrence Grades 2,3 Knee Osteoarthritis

Inclusion Criteria

Age From	40.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1.Diagnosed with knee osteoarthritis (Kellgren-Lawrence grade II or lI) 2. Presence of chronic knee pain for at least 3 months 3.Able and willing to provide informed consent 4.Willing to undergo intra-articular PRP injection and adhere to follow-up protocol 5. Seronegative Adults 6. Patients with Unilateral or Bilateral knee oA of grades 2-3 (KL classification) ; For B/L OA, the more symptomatic knee (acc. To VAS Score) will be selected, C/L knee must not have undergone PRP or intraarticular steroid injection in last 3 months.

ExclusionCriteria

Details

1.Advanced osteoarthritis (Kellgren-Lawrence grade 4)
2.History of inflammatory joint diseases (e.g., rheumatoid arthritis, gout)
3.Recent knee trauma or surgery within the past 6 months
4.Active joint infection or systemic infection

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Change in total WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) score from baseline to 6 months after intraarticular Platelet rich plasma injection	1Week,1Month,3Months,6Months,1Year

Secondary Outcome

Outcome	TimePoints
To Standardised The Quantity, Dosing, Volume Of Prp	1Week,1Month,3Months,6Months,1Year

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
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

N/A

Date of First Enrollment (India)

16/03/2026

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 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

PROPOSED TOPIC OF RESEARCH:“EFFICACY OF PLATELET RICH PLASMA(PRP)IN KL GRADES 2-3

OSTEOARTHRITIS OF KNEE JOINT IN PATIENTS ATTENDING A TERTIARY CARE HOSPITAL IN KOLKATA."

OBJECTIVES:To evaluate the efficacy of intra-articular Platelet-Rich Plasma (PRP)injection in reducing pain

and improving functional outcomes in patients with osteoarthritis KL Grade II-III of the knee joint using validated

scoring systems such as the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)&To evaluate the

duration of symptomatic relief (based on VAS Score)provided by a single PRP injection over a defined follow-up period for 1

year.To Standardised the Quantity,Dosing,Volume of PRP.

BACKGROUND OF PRESENT STUDY:

Osteoarthritis (OA)of the knee is a common degenerative joint disease and a major cause of disability among

the adult population worldwide.It is characterized by progressive loss of articular cartilage,synovial

inflammation,and changes in subchondral bone,leading to pain,stiffness,and decreased mobility[1].

Osteoarthritis,typically corresponding to Kellgren-Lawrence grade Il or III,provides a window for early

intervention before irreversible joint damage sets in[2].Platelet-Rich Plasma(PRP),an autologous bloodderived

product rich in growth factors,has gained attention for its potential to enhance cartilage repair and modulate

inflammation[3].Clinical studies have demonstrated that PRP may improve pain and function in early knee OA,

but inconsistent protocols Standardization and outcomes highlight the need for further research[4].

METHODOLOGY

This study will employ a Pre-Post Quasi Experiment design,analyzing data from patients diagnosed with

knee osteoarthritis (Kellgren-Lawrence grade II-III)who receive intra-articular PRP injections.Patient

demographics,including age,sex,body mass index (BMI),and physical activity level,will be recorded at

baseline.Baseline and follow-up assessments of pain,stiffness,and physical function will be conducted using

the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)&Visual Analog scale(VAS).

PRP preparation details,including volume,will also be documented.Statistical analyses will be performed to

evaluate changes in WOMAC scores over time and to determine associations between patient characteristics

and treatment outcomes,using paired t-tests and multiple regression analyses to identify significant

predictors of clinical improvement.

EXPECTED OUTCOME:The expected outcome of this study is that PRP injections will lead to a significant

improvement in pain relief,joint stiffness,and physical function as measured by WOMAC index and VAS