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CTRI Number  CTRI/2023/07/055142 [Registered on: 12/07/2023] Trial Registered Prospectively
Last Modified On: 12/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Surgical/Anesthesia
Screening 
Study Design  Other 
Public Title of Study   Use of biologics like Platelet rich plasma in osteoarthritis of knee for cartilage regeneration 
Scientific Title of Study   A study on Osteoarthritis of knee evaluating the effects of Biologics with Bio-mechanical correction for regeneration of cartilage. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditya Pundkar 
Designation  Associate Professor 
Affiliation  DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  Jawaharlal Nehru Medical college, Sawangi Meghe , Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9975170898  
Fax    
Email  draditya.pundkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Shrivastava 
Designation  Professor 
Affiliation  DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  Jawaharlal Nehru Medical college, Sawangi Meghe , Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9975170898  
Fax    
Email  drsandeepshrivastava@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Shrivastava 
Designation  Professor 
Affiliation  DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  Jawaharlal Nehru Medical college, Sawangi Meghe , Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9975170898  
Fax    
Email  drsandeepshrivastava@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College , Sawangi Meghe ,Wardha 442001 
 
Primary Sponsor  
Name  JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  Jawaharlal Nehru Medical college, Sawangi Meghe , Wardha 
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 Aditya Pundkar  Acharya Vinoba Bhave Rural Hospital  Department of Orthopaedics , Sawangi ,Meghe,Wardha
Wardha
MAHARASHTRA 		 9975170898

draditya.pundkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH Institutional ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PRP alone  The patient will be managed with PRP into the medial compartment of knee joint. MRI of the knee will be done on day 0 and at the end of 6 months to see the regeneration of cartilage . USG KNEE WILL BE DONE ON 0,3,12,Weeks and 6 months . Radiological evidence in form of x rays will also be taken. 
Intervention  PRP and proximal fibular osteotomy  The patient will be managed with proximal fibular osteotomy along with PRP infiltration into the knee joint of the operated side and the clinical outcome will be assessed at 0,3,12,24 weeks and 9 months.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1- Patients OA knee - Grade II and III
2- Radiological evidence of medial compartment involvement.
3- Primary OA knee patients.
4- Patients who are willing to take part in study after informed consent 
 
ExclusionCriteria 
Details  1-Post traumatic knee stifness
2-History of infective joint disease.
3-Patients with history of previous surgeries of knee.
4-Co-morbid/pathology of ipsilateral hip/foot joint pathology
5-Any other defect of ipsilateral limb like shortening etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Biomechanical correction with biologics (PRP) can lead to cartilage regeneration  at 0 , 3 , 12 , 24 weeks and 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Correction of varus deformity  Correction of varus deformity at 0, 6 , 12 , 24 weeks and 6 and 9 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   Phase 3 
Date of First Enrollment (India)   20/07/2023 
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="3"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 28-05-2023 and end date provided 23-05-2025?
    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   Osteoarthritis is the most common cause of disability in the older population.It is due to the wear of the cartilage. Direct infiltrate of Platelet rich plasma in the normal or near normal cartilage should trigger cartilage regeneration leading to filling up of the cartilage defect/improving the quality of remaining cartilage.Proximal fibular osteotomy should deload the medial compartment and further assist the prevention of cartilage regeneration by indirect prevention. 
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