FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072559 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 15/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study for assessing the better intra-articular injection for the treatment of mild to moderate knee arthritis  
Scientific Title of Study   Intra-articular Platelet Rich Plasma vs. Corticosteroid vs. Hyaluronic Acid in the Treatment of Mild and Moderate Osteoarthritis of knee  
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 Anooj Pravin Chheda  
Designation  Post Graduate ( M.S. Orthopaedics)  
Affiliation  SRM Institute of Science and Technology  
Address  G block, 2nd floor , Dept of Orthopaedics, SRM Medical College Hospital and Research Centre, Kattankulathur, Chennai 603202

Chennai
TAMIL NADU
603202
India 
Phone  9619450470  
Fax    
Email  ac2909@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr E Dilip Kumar Naidu  
Designation  Professor ( Dept of Orthopaedics)  
Affiliation  SRM Institute of Science and Technology  
Address  Dept of Orthopaedics, SRM Medical College Hospital and research Centre , kattankulathur , Chennai 603203

Chennai
TAMIL NADU
603203
India 
Phone  9884460536  
Fax    
Email  erraguntladilipnaidu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr E Dilip Kumar Naidu  
Designation  Professor ( Dept of Orthopaedics)  
Affiliation  SRM Institute of Science and Technology  
Address  Dept of Orthopaedics, SRM Medical College Hospital and research Centre , kattankulathur , Chennai 603203

Chennai
TAMIL NADU
603203
India 
Phone  9884460536  
Fax    
Email  erraguntladilipnaidu@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Centre  
 
Primary Sponsor  
Name  SRM Medical College Hospital and Research Centre  
Address  G block , 2nd floor , Dept of Orthopaedics , SRM Medical College Hospital and Research Centre , kattankulathur , Chennai 603203 
Type of Sponsor  Private 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 Anooj Chheda   SRM Medical College Hospital and Research Centre   G block , 2nd floor , SRM Medical College Hospital and Research Centre, kattankulathur , Chennai 603203
Chennai
TAMIL NADU 		 9619450470

ac2909@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Institutional Ethics Committee  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  40 mg of triamcinolone acetonide   Intra-articular injection given into the joint space  
Intervention  6 ml of Autologous platelet rich plasma   Intra-articular injection given into the joint space. 
Comparator Agent  6 ml of Hyaluronic acid   Intra-articular injection given into the joint space  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patient having old to moderate osteoarthritis of knee (kellgran lawrence classification grades 1,2,&3) . All patients above the age of 45 years  
 
ExclusionCriteria 
Details  Patients having secondary osteoarthritis of knee, having history of any previous knee surgeries for ligaments injuries / intra articular fractures. Any history of infections like TB/bacterial (post Septic Sequelae ). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of pain relief by the Visual Analogue Score (VAS).
Where 0 points equal to no pain and 10 points equal to worst pain  		 1 month, 3months, 6 months, 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Variations in the WOMAC scores ( Western Ontario and McMaster Universities Arthritis Index )
Where 0 points gives the best outcome and 96 points gives the worst outcome 		 1 month, 3months, 6 months, 12 months. 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   26/08/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - Researchers who provide a methodologically sound proposal.

  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 [ac2909@srmist.edu.in].

  6. For how long will this data be available start date provided 01-02-2025 and end date provided 28-02-2030?
    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 - Nil
Brief Summary   A total of 105 patients of age group between 45-75 of both genders will be assessed on the basis of kellgren Lawrence classification of osteoarthritis of knee. Patients will be divided into 3 groups . First group will be receiving 6 ml of rich autologous platelet rich plasma , Second group will receive 40mg of Triamcinilone Acetonide injection , Third group will receive 6 ml of Hyaluronic acid, all into the medial joint space of the knee under sterile aseptic conditions. Variations in VAS scoring system will be the primary outcome where 0 - no pain and 10- worst pain. Variations in the WOMAC scores will be the secondary outcomes where the patients daily activities of living will be scored based on their tolerance , 0 giving the best outcome and 96 giving the worst outcome. Data collection will be done by observation and various parameters.   
Close