| 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
|
|
|
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
|
|
|
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 |
|
|
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 tearâ€, 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 |