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CTRI Number  CTRI/2024/10/074922 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 13/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Bone Marrow Aspirate Concentrate Injection vs Steroid Injections For Pain In Knee Osteoarthritis 
Scientific Title of Study   Evaluating The Efficacy Of Intra-articular Bone Marrow Aspirate Concentrate Injection vs Steroid Injections For Pain And Function Improvement In Knee Osteoarthritis:A Short-Term Comparative Analysis 
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.Prabu.M 
Designation  Associate professor , Department of Orthopedic Surgery 
Affiliation  JIPMER 
Address  PMR rehabilitation block,next to general OPD , JIPMER
Dhanvantari nagar
Pondicherry
PONDICHERRY
605006
India 
Phone  08179258003  
Fax    
Email  prabublue@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Kadimisetti V N V S Neastham Reddy 
Designation  Junior Resident, Department of Orthopedic Surgery 
Affiliation  JIPMER 
Address  PMR rehabilitation block,next to general OPD , JIPMER Dhanvantari nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  8179258003  
Fax    
Email  vinayneastham@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Prabu.M 
Designation  Associate professor, Department of Orthopedic Surgery 
Affiliation  JIPMER 
Address  PMR rehabilitation block,next to general OPD , JIPMER,Gorimedu,Puducherry


PONDICHERRY
605006
India 
Phone  08179258003  
Fax    
Email  prabublue@gmail.com  
 
Source of Monetary or Material Support  
JIPMER IMRF , puducherry ,605006,India 
 
Primary Sponsor  
Name  JIPMER IMRF 
Address  JIPMER, Puducherry,Dhanvantari nagar ,Gorimedu,605006 ,India 
Type of Sponsor  Research institution and hospital 
 
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 Kadimisetti V N V S Neastham Reddy  Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER  PMR rehabilitation block,next to general OPD , JIPMER Dhanvantari nagar
Pondicherry
PONDICHERRY 
08179258003

vinayneastham@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER IEC INTERVENTIONAL   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intra articular Bone marrow aspirate concentrate injection   Bone marrow aspirate concentrate[ 4ml ] is injected intraarticularly in both knees from superolateral approach pointing towards opposite medial malleolus .It is one time procedure ,expected duration of procedure is 30 minutes for aspirating bone marrow ,2 hours for centrifugation and 15 minutes for injecting bone marrow aspirate concentrate. Patient will be followed up after 1 month and 3 months of intervention for assessment of pain.  
Comparator Agent  Intrarticular triamcinolone(steroid)   .Triamcinolone injection 1 ml containing 40 mg will be used for the procedure Triamcinolone is injected intraarticularly in both knees from superolateral approach pointing towards opposite medial malleolus. It is one time procedure ,expected duration of procedure is 30 minutes.Patient will be followed up after 1 month and 3 months of intervention for assessment of pain .  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Age ranging from 40 to 75 years
Osteoarthritis of medial or lateral compartment [1-2 -3grade according to Kellgren Lawrence score]
Failure of atleast 6 months of conservative management ]
Bilateral knee osteoarthritis
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of bone marrow aspirate concentrate injections compared to triamcinolone (corticosteroid) in improving short term clinical outcomes related to pain and function in patients with knee osteoarthritis  Followup period for 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
No secondary objective   Not applicable  
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   10/10/2024 
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="3"
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 - NO
Brief Summary   Background :Osteoarthritis (OA) is a chronic progressive degenerative disorder consisting of degeneration and loss of articular cartilage with accompanying synovitis, subchondral bone remodelling, and osteophyte formation . It constitutes a major cause of disability with pain, stiffness, resulting in severe functional limitations . 
Although OA is a process of articular cartilage “wear and tear”, its changes are biochemically mediated , through an imbalance between intra-articular anabolic and catabolic cytokines . This results in cartilage loss, synovial inflammation and eventually leads to mechanical and biological dysfunction of the joint .
The articular cartilage due to its avascular nature and the limited self-renewal capacity of chondrocytes has remarkably poorer regenerative ability than other tissues .
Rationale :Current treatments for early phase of degenerative arthritis focus on relieving inflammation and pain , but have no effect on the natural progression of the disease because it does not improve the biochemical environment (homeostasis) of the joint.
Conservative treatments including medications such as non-steroidal anti-inflammatory drugs (NSAIDs) and steroids as well as supplements including glucosamine, chondroitin sulphate, omega-3 fatty acids , cannot alter the natural history of the disease.Steroids focus on relieving inflammation and pain
Costly total knee arthroplasty (TKA) then follows when other treatment options have been exhausted , however patients experience a higher risk of death from mental and inflammatory musculoskeletal diseases, with a serious adverse event rate of 5.6% and a 0.2% mortality rate .
Novelty:Recently, extraction of the mesenchymal stem cells (MSCs) obtained from autologous bone marrow (BMA) followed by concentration was introduced represents the next generation of injectable intra-articular orthobiologic therapy for patients with cartilage disease . 
MSCs are multipotent cells that exhibit strong self-renewal abilities, combined with a differentiation capacity to form chondrocytes, adipocytes, and osteocytes . These cells also have very important local paracrine affects to alter their local microenvironment to conditions favourable for regeneration and repair .
BMAC represents the safest and most feasible source of MSCs. Intra-articular application has resulted in pain reduction, functional improvement and/or tissue regeneration . BMAC is obtained through density gradient centrifugation of bone marrow aspirate (BMA) typically aspirated from the iliac crest . BMAC has been shown to provide elevated levels of hematopoietic stem cells (HSCs), MSCs, platelets, chemokines and cytokines including PDGF and TGF-β .These growth factors (GFs) are not only contained within the alpha granules of platelets, but they are also secreted by MSCs and can induce chondrogenesis of MSCs . GFs also initiate stem cell migration to the injury site and provide adhesion sites for the migrating stem cells . Moreover BMAC possesses in general, anti-inflammatory, angiogenic trophic and immunomodulatory properties that can potentially have anabolic and anti-inflammatory effects enhancing cartilage repair .There are only very few studies comparing steroids with BMAC.
To date, there have been several studies that have looked at BMAC for the treatment of osteoarthritis, with conflicting results secondary to the differences and/or inconsistencies in methodologies used throughout the studies . Therefore, the role of BMAC in osteoarthritis is not yet been established
 
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