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CTRI Number  CTRI/2024/05/068055 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Injection of blood cell components in knee joint for joint pain patients  
Scientific Title of Study   Efficacy of intraarticular injection Of autologous platelet rich plasma in patients with knee osteoarthritis  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vignesh Rajan 
Designation  Junior Resident in Department of Anaesthesiology 
Affiliation  Gandhi medical college, bhopal 
Address  Operation Theatre ,2nd Floor , Department Of Anaesthesia Gandhi Medical College,hamidia Hospital

Bhopal
MADHYA PRADESH
462001
India 
Phone  9659395301  
Fax    
Email  drvigrajan1163@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Urmila keshari 
Designation  Professor in department of anaesthesia  
Affiliation  Gandhi medical college ,bhopal  
Address  Operation Theatre ,2nd Floor , Department Of Anaesthesia Gandhi Medical College,hamidia Hospital

Bhopal
MADHYA PRADESH
462001
India 
Phone  9862757745  
Fax    
Email  drsurmi@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jaideep singh 
Designation  Associate Professor in department of anaesthesia  
Affiliation  Gandhi medical college ,bhopal  
Address  Operation Theatre ,2nd Floor , Department Of Anaesthesia Gandhi Medical College,hamidia Hospital

Bhopal
MADHYA PRADESH
462001
India 
Phone  9827767022  
Fax    
Email  singhdrjaideep@gmail.com  
 
Source of Monetary or Material Support  
Gandhi medical college, hamidia hospital, Bhopal Madhya pradesh 462001 
 
Primary Sponsor  
Name  Gandhi medical college  
Address  Gandhi medical college Hamidia Hospital Bhopal Madhya pradesh 462001 
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 Vignesh rajan   Gandhi medical college   Room no 2,operation theatre,2nd floorGandhi Medical College,hamidia Hospital
Bhopal
MADHYA PRADESH 
9659395301

drvigrajan1163@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,Gandhi medical college bhopal  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injecting the platelet rich plasma in knee joint   15-20 ml of blood withdrawn and prp is made and injected in to knee joint as regenerative therapy.this will be done once In a week for 3 consecutive weeks and pain scoring will be assessed at end of 3 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient with knee joint swelling/pain for more than 3 months
Xray showing degenerative changes  
 
ExclusionCriteria 
Details  Patient refusal or not giving consent
Infected knee joint /(Osteomyelitis)
Hb<10gm/dl
Platelet < 1.5 lakh cells/mm3 Pregnantwomen/breast feeding women
Any Hematological disorders like CLL, ALL, AML Rheumatological disorders like RA, SLE Osteoarthritis grade I & IV 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the therapeutic effectiveness of PRP as a intraarticular injection to knee joint for OA patients by Womac scoring  In 3 sitting of injection in gap of 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Occurrence of side effects and complications   In 3 sitting of injection in gap of 1 week 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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 2 
Date of First Enrollment (India)   10/06/2024 
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)   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 - NO
Brief Summary   Osteoarthritis is a degenerative disease involving joint damage, an inadequate healing response and progressive deterioration of the joint architecture the commonly affects the knee joints. The most common conservative management for osteoarthritis is NSAIDS drugs, chondroitin sulfate, glucocorticoid. However these methods have various adverse effect & healing ability of cartilage tissue is not up to the mark.so it can give only short time resolution. • Autologous blood derived products possess much promise in the repair and regeneration of tissue and have important role in inflammation, angiogenesis, cell migration and metabolism in pathological conditions including osteoarthritis • PRP is an autologous mixture of highly concentrated platelets and associated growth factors and other bioactive components produced by centrifugal separation of whole blood that is mostly used in orthopaedic and sports medicine practice to treat bone, tendon and ligament injuries. • PRP may induce a regenerative response by improving the metabolic function of damaged structures • PRP also contains high concentration of growth factors,VEGF,PDGF,TGFbeta • The supra-physiological release of platelet derived growth factors directly at the site of cartilage disease, may stimulate the natural regenerative signalling cascade and enhance the healing of tissue with further mediation of the anti-inflammatory response The Ultimate aim of the study to assess the therapeutic effectiveness of platelet rich plasma as intraarticular knee joint injection for a patients with osteoarthritis by using WOMAC scoring 

This study includes the sample size of between 4070 86 patients belong the age group year and history of knee pain more than 3 months hi story of patient was taken in pain clinic and they underwent . Detailed a thorough physical examination. Patient s fulfilling the criteria were explained about treatment modality in detail and informed consent was obtained & their pain sc ore by WOMAC scoring was assessed
P latelet Rich Plasma(PRP) PREPARATION : About 30 ml of patients blood was taken from vials 4.2ml of acid dextrose solution in sterile 5 ml of PRP. antecubital vein and mixed with to get about 3 and it centrifuged telet After centrifuging the concentration of pla patients blood was assessed. Procedure: in PRP and After all those initial preparation, the patient was taken to operating with proper monitoring with pulse oximeter, ECG, non invasive blood pressure through room out the procedure. Two large IV cannula was established and one unit of RL was started in one IV cannula and inj. Ondansetron 4mg IV , inj. Midazolam 1mg IV , inj. Fentanyl 25 mcg was given as antiemetic, anxiolytic, analgesic basis respectively. Patient was lies on his back , exposing slightly flexed the knee joint and the affected knee joint . Routine disinfection was done with iodophor . inj. lignocaine p 2% was infiltrated in to the skin / subcutaneous tissue. And then 3 ml of autologous PRP was administered in the patellofemoral joint space at outer edge of patella and then knee joint was slightly flexed and extended for several times to ma ke sure PRP fully cover the articular surface. After the injection patient was instructed to avoid strenuous same exercise And the procedure was done once in a week for a 3 consecutive week After the 3 shot of PRP injection in 3 consecutive week, the patients WOMAC score was assessed and it was compared with their initial WOMAC scoring.
 
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