| CTRI Number |
CTRI/2025/11/097973 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Bone Marrow Aspirate in Primary Knee Osteoarthritis |
|
Scientific Title of Study
|
Comparative analysis of Bone Marrow Aspirate versus Bone Marrow Aspirate Concentrate in Primary Knee Osteoarthritis - An Unicentric, double blinded, randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwini R |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of medicine- Sri Lalithambigai Medical College and Hospital |
| Address |
Department of Orthopaedics, Faculty of medicine- Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, India
Chennai
TAMIL NADU
600095
India |
| Phone |
9790877011 |
| Fax |
|
| Email |
ashwini.rajangam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhan Jeyaraman |
| Designation |
Associate Professor |
| Affiliation |
Faculty of medicine- Sri Lalithambigai Medical College and Hospital |
| Address |
Department of Orthopaedics, Faculty of medicine- Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, India
Chennai
TAMIL NADU
600095
India |
| Phone |
8310600785 |
| Fax |
|
| Email |
madhanjeyaraman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashwini R |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of medicine- Sri Lalithambigai Medical College and Hospital |
| Address |
Department of Orthopaedics, Faculty of medicine- Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, India
Chennai
TAMIL NADU
600095
India |
| Phone |
9790877011 |
| Fax |
|
| Email |
ashwini.rajangam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ashwini R |
| Address |
Department of Orthopaedics, Faculty of Medicine - Sri Lalithambigai Medical College and Hospital, Chennai, Tamil Nadu |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Madhan Jeyaraman |
Faculty of Medicine - Sri Lalithambigai Medical College and Hospital |
Department of Orthopaedics, Faculty of Medicine - Sri Lalithambigai Medical College and Hospital
Chennai
TAMIL NADU |
08310600785
madhanjeyaraman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Faculty of Medicine - Sri Lalithambigai Medical College and Hospital |
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 |
| Comparator Agent |
Bone Marrow Aspirate |
Group C: Single dose of 5 ml subchondral BMA (both tibial and femoral medial condyles) on day 0
Group D: Single dose of 5 ml intraarticular BMA injection on day 0
|
| Intervention |
Bone Marrow Aspirate Concentrate |
Group A: Single dose of 5 ml subchondral BMAC (both tibial and femoral medial condyles) on day 0
Group B: Single dose of 5 ml intraarticular BMAC injection on day 0
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age between 40 to 60 years of both sex
Patients OA knee with Grade II and III.
Primary OA knee patients not responding to analgesics
Patients who are willing to take part in the study after informed consent |
|
| ExclusionCriteria |
| Details |
Post traumatic knee Stiffness
History of Infective joint disease
Patients with a history of previous surgeries on the knee
Comorbid or Pathology of ipsilateral Hip or foot joint pathology
Patients with rheumatoid arthritis, inflammatory arthritis or polyarticular arthritis, and autoimmune diseases
Any other defect of the ipsilateral limb like Shortening
Patients with history of prior corticosteroid injection at treatment site within 3 months of duration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the pain relief of BMAC versus BMA injections in primary osteoarthritis knee with VAS score at different follow-up time points.
|
Day 0
At the end of 1,3,6,12,24 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the functional outcome of BMAC versus BMA injections in primary osteoarthritis knee with WOMAC and KOOS |
Day 0
At the end of 1,3,6,12,24 months
|
| To compare the cartilage thickness and the healing of subchondral bone lesions of BMAC and BMA in primary osteoarthritis knee via MOCART |
Day 0
At the end of 24 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/12/2025 |
| 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="2"
Months="6"
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 - NO
|
|
Brief Summary
|
This study protocol outlines a double-blinded, unicentric randomized controlled trial comparing Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC) in treating primary knee osteoarthritis. Conducted at Sri Lalithambigai Medical College and Hospital, it aims to evaluate pain relief (VAS), functional outcomes (WOMAC, KOOS), and cartilage healing (MOCART via MRI) over a 2-year follow-up. Two hundred patients aged 40–60 with Grade II–III OA will be randomized into four groups receiving either subchondral or intraarticular BMA/BMAC injections. The study fills a gap in literature, as BMA has not been previously studied for knee OA. Data will be collected using validated scoring tools and analyzed using SPSS/R. Ethical safeguards include anonymized data, informed consent, and minimal risk. The study is expected to provide insights into the comparative efficacy of BMA and BMAC, potentially influencing clinical practice and future research. A detailed timeline spans literature review, data collection, model development, and dissemination over 30 months. Supporting documents include participant information sheets, consent forms, and investigator declarations. The protocol adheres to ICMR and GCP guidelines, with institutional approvals in place. Ultimately, the research aims to expand therapeutic options for OA knee and contribute to evidence-based regenerative orthopaedic care. |