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CTRI Number  CTRI/2026/04/107952 [Registered on: 09/04/2026] Trial Registered Prospectively
Last Modified On: 09/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing bone marrow aspiration concentrate vs own bone graft in single level spinal fusion  
Scientific Title of Study   Efficacy of bone marrow aspirate concentrate (BMAC) as compared to autograft in achieving spinal fusion in patients undergoing single level transforaminal lumbar interbody fusion (TLIF) - a Pilot RCT 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr MOHAMMED IRFAN M P 
Designation  JUNIOR RESIDENT 
Affiliation  JIPMER, Puducherry 
Address  Department of orthopedics JIPMER, Dhanavantari Nagar Puducherry,605006

Pondicherry
PONDICHERRY
605006
India 
Phone  8921352551  
Fax    
Email  mohirfanmp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Pasupathy. P 
Designation  Associate Professor  
Affiliation  JIPMER, Puducherry 
Address  Department of Orthopaedics JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8921352551  
Fax    
Email  drastos@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr MOHAMMED IRFAN M P 
Designation  JUNIOR RESIDENT 
Affiliation  JIPMER, Puducherry 
Address  Department of orthopedics JIPMER, Dhanavantari Nagar Puducherry,605006

Pondicherry
PONDICHERRY
605006
India 
Phone  8921352551  
Fax    
Email  mohirfanmp@gmail.com  
 
Source of Monetary or Material Support  
JIPMER, Dhanavantari Nagar Puducherry,605006 
 
Primary Sponsor  
Name  JIPMER 
Address  Dhanavantari nagar Puducherry 605006 
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 Mohammed Irfan M P  JIPMER, Puducherry  Department of Orthopeadics, Dhanavantari nagar, Puducherry 605006
Pondicherry
PONDICHERRY 		 08921352551

mohirfanmp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-INSTITUTIONALINTERVENTIONALSTUDIESJIPMER, PUDUCHERRY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  autograft  Surgical Procedure: A single-level TLIF will be performed under standard surgical protocols. The graft material (autograft) harvested from the spinous process and lamina will be packed into the disc space and the interbody cage. 
Intervention  bone marrow aspirate concentrate   The bone marrow needle assembly, syringes, and filters will be washed with heparin. Eight 10-mL syringes, each containing 1.5 mL of anticoagulant citrate dextrose solution A (ACD-A), will be utilized for the bone marrow aspiration. Patient will be placed in prone position. The areas of aspiration will be sterilely prepared and draped as per standard protocol. Under general anesthesia before starting the TLIF surgery, a bone marrow aspiration needle will be employed, and the total resultant volume of 50 ml (including ACD -A) will be collected from posterior iliac crest. Single-needle insertion with redirection (SS method): A small incision will be placed at the desired site with a scalpel. A reusable 11-gauge bone marrow aspiration needle will be used. The needle is inserted through the incision site and rotated with careful pressure until it goes through the cortex. Once placed, the trocar will be advanced 2 cm before the introducer is removed. A 10-mL syringe with 1.5 mL of ACD-A is then attached to the trocar. A total of 8.5 mL of bone marrow will be aspirated at this depth as follows: 3 mL will be aspirated after trocar removal; then, the needle was rotated 90° clockwise, and an additional 3 mL will be aspirated. A final 2.5 mL of aspirate is obtained following another 90° of rotation. The first 10-mL syringe is removed and sterilely capped. The trocar will be then pulled back 0.5 cm, and a new 10-mL syringe with 1.5 mL of ACD-A is employed via the same “aspirate-rotate-aspirate” technique, adding an additional 8.5 mL of BMA to the total. This second 10-mL syringe will be sterilely capped. Again, the trocar is pulled back another 0.5 cm, and the same “aspiraterotate-aspirate” technique will be employed, adding 8.5 mL of BMA to the total. After 34 mL of BMA is harvested (with 6 mL of ACD-A), the introducer will be placed back into the trocar, and the device will be redirected 30° laterally and advanced 2 cm. Again, a 10-mL syringe with 1.5 mL of ACD-A will be used, and the “aspirate-rotate-aspirate” technique described above is employed, adding 8.5 mL of BMA. The full 10-mL syringe will be capped, and a new 10-mL syringe with 1.5 mL of ACD-A will be placed. As previous, the trocar will be pulled back 0.5 cm, and the same “aspirate-rotate-aspirate” technique is employed till 80 ml of bone marrow aspirate [including ACD -A] is obtained[20] The aspirated marrow and ACDA will be then passed through a sterile 150-mm filter into 50 ml conical tubes to remove particulate matter. One milliliter of this filtered material will be sent for laboratory analysis and the rest will be sent for centrifugation. Once the BMAC is obtained, it will be transported back to the OT in a sterile container.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18-65 Years
Patients undergoing single level TLIF
 
 
ExclusionCriteria 
Details  Previous spinal surgery at the same level
Presence of infection or malignancy in the spine
Presence of infection or malignancy at the donor site
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To determine the feasibility of achieving spinal fusion using BMAC in patients undergoing single level TLIF
2. To compare the rate of spinal fusion achieved by BMAC and autograft in patients undergoing single level TLIF 		 Initially 6 week post op, followed by 3 months and then 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary to compare the rates of the cage migration implant failure infection & reoperation between the groups  Initially 6week post op followed by 3 months & then 6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/05/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Transforaminal lumbar interbody fusion (TLIF) is an established approach to spinal fusion surgery that involves accessing the lower spine through the inter-vertebral foramina. The vertebral disc is subsequently removed, and a bone graft is placed to fuse the adjacent vertebral bodies. However, Autograft is considered the biologically most suitable graft material due to its osteogenic and osteoconductive properties. The use bone graft in spine surgeries mainly targeted to achieve bone healing and fusion between the affected vertebrae. Most of studies point out that autograft contributes to good fusion rates, and decreases the need of re operation.
 Although studies have highlighted the postoperative complications and patient dis-satisfaction due to discomfort from the harvest site. Therefore, there has been a large push to discover alternative bone graft fusion materials. 
 Several options have gained substantial attention and are being studied to determine their efficacy. With the modernization of biotechnology, there has been a concerted effort to develop novel biomaterials that can be used to augment spine surgery.
 An alternative method is the use of BMA, a method that has become popular in Orthopaedics at the end of the last century and the beginning of the present. This orthobiologic product has been used in many treatments of some musculoskeletal disorders, such as non-union, bone defects, arthritis, ligament tears, and osteonecrosis of the femoral head.
BMAC from patient own bone marrow contain stem cell and growth factor that promote healing.
 
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