FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075179 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 22/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of intraarticular injections of Platelet Rich Plasma and Platelet Rich Fibrin in patients with early osteoarthritis of knee  
Scientific Title of Study   A comparative study of clinico-functional outcomes of intraarticular Platelet Rich Plasma and Platelet Rich Fibrin in the management of early osteoarthritis of knee – prospective randomized control trial 
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 Ankit 
Designation  Junior Resident 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Room no:6, Department of Orthopedics, RL Jalappa Hospital, Sri Devaraj Urs Academy of Higher Education and Research

Kolar
KARNATAKA
563103
India 
Phone  7840820204  
Fax    
Email  AHOODA581@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hariprasad S 
Designation  Professor and Head of Unit, Department of Orthopedics, Sri Devaraj Urs Medical College  
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Room no:6, Department of Orthopedics, RL Jalappa Hospital, Sri Devaraj Urs Academy of Higher Education and Research

Kolar
KARNATAKA
563103
India 
Phone  9686071188  
Fax    
Email  DRHARIPRASAD.ORTHO@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  Dr Hariprasad S 
Designation  Professor and Head of Unit, Department of Orthopedics, Sri Devaraj Urs Medical College  
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Room no:6, Department of Orthopedics, RL Jalappa Hospital, Sri Devaraj Urs Academy of Higher Education and Research

Kolar
KARNATAKA
563103
India 
Phone  9686071188  
Fax    
Email  DRHARIPRASAD.ORTHO@GMAIL.COM  
 
Source of Monetary or Material Support  
RL Jalappa hospital and research centre, Tamaka, Kolar, Karnataka 563103 
 
Primary Sponsor  
Name  Dr Ankit 
Address  Room no 221, Men PG hostel, Sri Devaraj Urs Medical College, Kolar, Karnataka India 563103 
Type of Sponsor  Other [self] 
 
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 Ankit  RL Jalappa Hospital   Room no:6, Department of Orthopedics, RL Jalappa Hospital, Sri Devaraj Urs Medical College, Kolar 563103 Karnataka India
Kolar
KARNATAKA 
7840820204

AHOODA581@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CENTRAL ETHICS COMITTEE OF SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH  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 
Comparator Agent  Plasma rich fibrin  Platelet-rich fibrin (PRF) is an autologous cicatricial matrix. The biologic activity of the fibrin molecule is enough in itself to account for the significant cicatricial capacity of the PRF and the slow polymerization mode confers to the PRF membrane a particularly favorable physiologic architecture to support the healing process. A one time dose of 8ml plasma rich fibrin will be injected via intraarticular route knee joint. Patients will be evaluated after the procedure at 2nd, 4th, 8th, 12th, 24th weeks respectively. 
Intervention  Plasma rich platelets  Concentrated platelets, derived from autologous blood, are concentrated into a polymer called platelet-rich plasma (PRP). PRP has chemotactic and mitogenic properties and functions as a growth factor agonist. The combination of large amounts of activated platelets, growth factors, and anti-inflammatory compounds alters the healing cascade and inflammatory pathway, reversing the degenerative process. A one time dose of 8ml plasma rich platelet will be injected via intraarticular route knee joint. Patients will be evaluated after the procedure at 2nd, 4th, 8th, 12th, 24th weeks respectively. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with early OA knee and Kellgren and Lawrence Scale (K&L) stage I and II.
Patient with persistent symptoms (pain, joint stiffness etc) irrespective of being treated with conservative treatment, including physical therapy, manipulation.
Patients were not under any other treatments for Osteoarthritis in the last month besides occasional analgesics.
 
 
ExclusionCriteria 
Details  Patients with severe osteoarthritis ( K& L stage III and IV)
Patient treated with long release corticosteroids infiltration over the last month
Patient on immune suppresor or chemotherapy treatment
Local/ general infections; patient with previous joint replacement
Actue rheumatoid arthritis and rheumatoid immune diseases
Low platelets (100,000) or low fibrinogen 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the clinico-functional outcome of intraarticular platelet rich plasma and platelet rich fibrin in the management of early osteoarthritis of knee at 24th week  24th week 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the clinico-functional outcome of intraarticular platelet rich plasma & platelet rich fibrin in the management of early osteoarthritis of knee at 2nd week, 4th week, 8th week, 12th week,24th week  2nd week, 4th week, 8th week, 12th week, 24th week 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)
Modification(s)  
01/05/2024 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  Demographic data, results and conclusions of the study will be shared

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) -  Researchers who have taken permission of the authors in this study

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [AHOODA581@GMAIL.COM].

  6. For how long will this data be available start date provided 01-03-2026 and end date provided 31-12-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NO
Brief Summary  



SL.

PARTICUARS

COMMENTS

1.

Name of the PG student

DR. ANKIT

2.

Name of the Guide

DR. HARIPRASAD S.

3.

Title of the Topic

A COMPARATIVE STUDY OF CLINICO-FUNCTIONAL OUTCOMES OF INTRAARTICULAR PLATELET RICH PLASMA AND PLATELET RICH FIBRIN IN THE MANAGEMENT OF EARLY OSTEOARTHRITIS OF KNEE – PROSPECTIVE RANDOMIZED CONTROL TRIAL

 

4.

Need for the study

PRP exerts its therapeutic mechanism via growth factors stored in the α-granule of platelets. Platelet-rich plasma has been proven to decrease inflammation, produce high-quality synovial fluid, and reconstruction of degenerative cartilage but its efficacy is yet be proven in conditions like osteoarthritis for long term results.

PRF showed promising properties in connective tissue regeneration and it is now widely applied in chronic wound healing and degenerative conditions. Patient treated with PRF showed better pain control and more persistent pain relief in short and mid-term than those treated with platelet rich plasma.

At present many studies have been done to examine the effectiveness of PRP and PRF individually, but a comparative study with a long term follow-up is yet to be performed.

5.

Objectives of the study

·       To assess the clinico-functional outcomes of intra-articular injection of PRP in early OA knee using Visual Analogue Scale (VAS) and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) at pre-procedure, post-procedure, 2nd, 4th, 8th, 12th, 24th weeks respectively.

·       To assess the clinico-functional outcomes intra-articular injection of PRF in early OA knee using VAS and WOMAC Osteoarthritis Index at pre-procedure, post-procedure, 2nd, 4th, 8th, 12th, 24th weeks respectively.

·       To compare clinico-functional outcomes intra-articular injection of PRP vs PRF in early OA knee knee using VAS and WOMAC Osteoarthritis Index at pre-procedure, post-procedure, 2nd, 4th, 8th, 12th, 24th weeks respectively.

 

7.

Material and Methods

STUDY DESIGN:

 

A prospective comparative randomized control trial.

 

To avoid patient selection bias patients will be grouped into two groups.  Patients will be randomly selected as per the randomization list generated by www.randomizer.org .

 

 8.

Method of collection data including sampling procedure

SOURCE OF DATA:

A comparative prospective study will be conducted at R.L Jalappa hospital and research center attached to Sri Devaraj Urs Medical college, affiliated to SDUAHER, from MAY 2024 to OCTOBER 2024. 126 patients with early Osteoarthritis of knee will be included in the study.

After full filling the inclusion criteria and exclusion criteria, informed and written consent will be obtained from all patients who agree to be a part of the study

  Patients will be divided into 2 groups

•        Group A included 63 patients who were treated with intra-articular Platelet Rich Plasma injection

•        Group B included 63 patients who were treated with intra-articular Platelet rich fibrin injection.

 

INCLUSION CRITERIA: 

·       Patients of either gender, aged between 45 to 70 years

·       Patients with early OA knee and Kellgren and Lawrence Scale (K&L) stage I and II

·       Patient with persistent symptoms (pain, joint stiffness etc) irrespective of being treated with conservative treatment, including physical therapy, manipulation

·       Patients were not under any other treatments for Osteoarthritis in the last month besides occasional analgesics

EXCLUSION CRITERIA:

·       Patients with severe osteoarthritis (K&L stage III and IV)

·       Patients treated with long release corticosteroids infiltration over the last month

·       Patients on immune suppressor or chemotherapy treatments

·       Acute rheumatoid arthritis and rheumatoid immune diseases

·       Local/general infections; patients with previous joint replacement

·       Low platelets (<100.000) or low fibrinogen

 

 
Close