FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083060 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Understanding development of osteoarthritis subsequent to injury to knee joint  
Scientific Title of Study   A study on association of inflammatory ,genetic and epigenetic markers with Kellgren Lawrence grading in post traumatic 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  Keerthy Rethinam M 
Designation  PhD scholar 
Affiliation  Sri Ramachandra Institute of higher education and research 
Address  Department of Biochemistry 3F wing ,Third floor , Medical college building, Sri Ramachandra institute of higher education ,Porur

Chennai
TAMIL NADU
600116
India 
Phone  9597790738  
Fax    
Email  keerthyrethinamm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Santhi Silambanan 
Designation  Professor  
Affiliation  Sri Ramachandra Institute of higher education and research 
Address  Department of Biochemistry 3E wing ,Third floor , Medical college building , Sri ramachandra institute of higher education and research Porur

Chennai
TAMIL NADU
600116
India 
Phone  09597790738  
Fax    
Email  santhisilambanan@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Santhi Silambanan 
Designation  Professor  
Affiliation  Sri Ramachandra Institute of higher education and research 
Address  Department of Biochemistry 3E wing, Third floor , Medical college building , Sri ramachandra institute of higher education and research Porur

Chennai
TAMIL NADU
600116
India 
Phone  09597790738  
Fax    
Email  santhisilambanan@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Indian council of medical research (ICMR), V .Ramalingaswami Bhawan, P.O.Box no -4911, Ansari nagar , New delhi -110029 India 
 
Primary Sponsor  
Name  Indian council of medical research ICMR 
Address  V.Ramalingaswami bhawan, P.O .Box no : 4911, Ansari nagar New delhi-110029, India 
Type of Sponsor  Government funding agency 
 
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 Keerthy Rethinam M  SRIHER  Department of sport medicine and arthroscopy & department of biochemistry 3E ,third floor SRIHER Porur Chennai
Chennai
TAMIL NADU 		 9597790738
04424767008
keerthyrethinamm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M15-M19||Osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  H/O Knee injury within 3 months  
 
ExclusionCriteria 
Details  History auto immune diseases
Any ohter chronic medical ilness
Post menopausal women
H/O Viscosupplementaion or vit D 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We can initiate treatment and screening procedures in handling osteoarthritis subsequent to trauma  Baseline,6 months and 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
Normal joint or OA joint   12 months 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="70" 
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)   19/04/2025 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response (Others) -  Similar type of studies

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [keerthyrethinamm@gmail.com].

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 01-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study participants are inducted into the study after getting written informed consent. They are identified by the consultants in the departments of Arthroscopy and Sports medicine. Individuals in the age group of 20-50 years who give history of injury to the knee joints in less than 3 months are included. All the participants are subjected to clinical examination, objective pain scoring, standard knee outcome score visual-analogue scale (VAS) and WOMAC .X ray will be taken .Blood and urine samples will be collected.The samples will be analysed for biomarkers .Statistical analysis will be done . 
Close