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CTRI Number  CTRI/2025/07/092111 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective study 
Study Design  Other 
Public Title of Study   A Study on How a Treatment Made from the Person’s Own Blood Helped People with Knee Pain Feel Better 
Scientific Title of Study   Platelet-Rich Plasma in Osteoarthritis of Knee: A Retrospective Study on Functional Improvement and Quality of Life 
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 Arvind Kumar Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj,Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arvind Kumar Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj,Madhupuri, Uttar Pradesh 229405


UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arvind Kumar Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj,Madhupuri, Uttar Pradesh 229405


UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh 
Address  All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arvind Kumar Sharma  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh  Room 22/28, Ground floor, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd,Munshiganj,Madhupuri, Uttar Pradesh 229405
Rae Bareli
UTTAR PRADESH 
6388930133

arvindkgmu25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), AIIMS Raebareli, Uttar Pradesh, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with Osteoarthritis of knee upto Grade 3 according to Kellgren Lawrence radiological grading
Patients who have received PRP intra articular injections
Age more than 18 years
 
 
ExclusionCriteria 
Details  Patients who were not compliant, lost to follow-up
Patient with multiple comorbidities like uncontrolled Diabetes Mellitus, Coronary Artery Disease, Chronic Kidney disease.
Patients with inflammatory diseases, such as Axial spondyloarthropathy, Rheumatoid arthritis etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale (NPRS)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Knee injury and Osteoarthritis Outcome Score (KOOS)
 
at baseline, 1month, 3months and 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
SF-12 Health Survey for quality of life  at baseline, 1month, 3months and 6 months  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   11/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

Title: Platelet-Rich Plasma in Osteoarthritis of Knee: A Retrospective Study on Functional Improvement and Quality of Life

Aim: To study the outcome of using Platelet-rich plasma in pain relief for patients with Osteoarthritis of knee joints

Primary objectives:

To quantitatively evaluate the reduction in knee joint pain following intra-articular administration of Platelet-Rich Plasma (PRP) in patients diagnosed with knee osteoarthritis.

To assess the extent of functional improvement post-PRP intervention in individuals with knee osteoarthritis, in terms of gait ability, joint range of motion, and performance in activities of daily living.

To compare clinical outcomes between patients with Grade 2 and Grade 3 (based on Kellgren-Lawrence classification) osteoarthritis of the knee, based on the, with respect to pain reduction and functional enhancement following PRP therapy.

Secondary objectives:

To assess improvement of quality of life (QOL) after PRP.

To identify factors influencing treatment response, such as age, BMI, baseline severity of symptoms, or comorbidities.

To evaluate the effect of home environment and living situation on outcomes in patients with OA knee.

To analyze the duration of symptomatic relief and functional gains post-PRP injection over the follow-up period.

Osteoarthritis (OA) is a common progressive degenerative condition affecting weightbearing joints, commonly the knee joints. Platelet-rich plasma (PRP) refers to a portion of plasma that contains a platelet concentration significantly higher than that found in normal peripheral blood. It is prepared by centrifuging a sample of the patient’s blood at high speed, which separates the red blood cells from the plasma. Various growth factors and cytokines are released after the degranulation of platelets and to accelerate cartilage matrix synthesis, restrain synovial membrane inflammation, and promote cartilage healing. Owing to the properties of regenerative effect and anti-inflammatory potential, PRP is widely used in musculoskeletal diseases, such as OA knee.

Materials and Methods

Study Type: Retrospective study

Study duration: 6 months

Study Design: This study will be conducted in the Department of Physical Medicine and Rehabilitation (PMR) at the All India Institute of Medical Sciences (AIIMS), Raebareli, Uttar Pradesh, India.

Eligibility criteria:

Inclusion Criteria:

Patients with Osteoarthritis of knee upto Grade 3 according to Kellgren Lawrence radiological grading

Patients who have received PRP intra articular injections

Age more than 18 years

Exclusion Criteria:

Patients who were not compliant, lost to follow-up

Patient with multiple comorbidities like uncontrolled Diabetes Mellitus, Coronary Artery Disease, Chronic Kidney disease.

Patients with inflammatory diseases, such as Axial spondyloarthropathy, Rheumatoid arthritis etc.

Procedure: Patients who had visited the out-patient and in-patient Dept of PMR during the time period of May 2022 till May 2025 have been included in the study.

Demographic details and evaluation of history, complete physical examination, values of functional scales (NPRS, WOMAC, KOOS scales) will be noted in a working case proforma.

The subjects’ response of change of severity of pain will be assessed using Numerical Pain Rating Scale (NPRS). Assessment of function and ability to carry out ADL will be assessed using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS).

Data collection: Data collection of outcome variables will be done at baseline, 1month, 3months and 6 months on OPD visits, following the first admission in IPD.

 

 
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