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CTRI Number  CTRI/2025/07/091598 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison the treatment of delayed union and non union of long bones using fresh frozen allograft with bone marrow aspirate vs autograft. 
Scientific Title of Study   Comparison Between Fresh Frozen Allograft With Bone Marrow Aspirate Versus Iliac Crest Autograft In Treatment Of Delayed Union And Non-union Of Long Bones. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IECHR-2025-69-20-R1  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhishek Yadav 
Designation  Post Graduate Resident 
Affiliation  University College Of Medical Sciences and Guru Teg Bahadur Hospital , New Delhi. 
Address  ward 20, Department Of Orthopaedics,University College Of Medical Sciences and Guru Teg Bahadur Hospital,2, Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095

East
DELHI
110095
India 
Phone  6398363693  
Fax    
Email  ab.ydv.752@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajesh arora 
Designation  Associate Professor 
Affiliation  University College Of Medical Sciences and Guru Teg Bahadur Hospital , New Delhi. 
Address  Room No. 15 ,ward 11 , 1st Floor , Ward block , Department of Orthopaedics, University College Of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi
2, Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095
North East
DELHI
110095
India 
Phone  9654453384  
Fax    
Email  rajeshmamc@gmai.com  
 
Details of Contact Person
Public Query
 
Name  Rajesh arora 
Designation  Associate Professor 
Affiliation  University College Of Medical Sciences and Guru Teg Bahadur Hospital , New Delhi. 
Address  Room No.15,ward 11 , 1st Floor , Ward block , Department of Orthopaedics, University College Of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi
2, Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095
North East
DELHI
110095
India 
Phone  9654453384  
Fax    
Email  rajeshmamc@gmai.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences And Guru Teg Bahadur Hospital.2, Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095 , India. 
 
Primary Sponsor  
Name  Abhishek Yadav 
Address  ward 20, Department Of Orthopaedics, University College Of Medical Sciences and Guru Teg Bahadur Hospital,2, Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095  
Type of Sponsor  Other [self] 
 
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 Abhishek Yadav  University College Of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi.  ward 20, Department Of Orthopaedics,University College Of Medical Sciences and Guru Teg Bahadur Hospital,2, Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095
North East
DELHI 
9458591420

ab.ydv.752@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Human research (IEC-HR)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bone Grafting using Fresh Frozen Allograft With Bone Marrow Aspirate  Fresh frozen Allograft with Bone Marrow Aspirate used in treatment of delayed union and non union of long bones Will be done till December 2026. 
Comparator Agent  Bone Grafting using Iliac Crest Autograft  Iliac Crest Autograft used in treatment of delayed union and non union of long bones 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients of with delayed/non-unions of fracture of long bones (tibia/femur/humerus/ either or both forearm bones) 
 
ExclusionCriteria 
Details  1.Active systemic or local infections.
2.Fracture gap more than 4 cm (post-debridement)
3.Immunosuppressed patients
4.Uncontrolled diabetes mellitus.
5.Psychiatric illness.
6.Substance abuse.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the fracture union in both treatment groups using mRUST score (modified Radiographic Union Scale for Tibia).  3 months , 6 months and 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the need for revision surgeries or additional interventions in each group.  Till 9 Months 
To document the complication including infection, graft-related issues & etc.  Till 9 months. 
To assess the VAS (Visual Analogue Score) at 48 hours, 2 weeks & 6 weeks post operative period.  48 hours, 2 weeks & 6 weeks post operative period. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   03/08/2025 
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="1"
Months="6"
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  

Autologous iliac crest bone graft (ICBG) has long been considered the gold standard for the treatment of long bone non-unions due to its inherent osteogenic, osteo-inductive, and osteoconductive properties . However, harvesting ICBG is not without drawbacks. Donor site morbidity such as chronic pain, hematoma, infection, and gait disturbance has been reported in up to 20%-30% of patients, along with limitations in the volume of graft that can be safely harvested . In an effort to mitigate these challenges, biologic alternatives like Bone Marrow Aspirate (BMA) combined with cancellous allograft have gained attention. BMA is a rich source of mesenchymal stem cells (MSCs), hematopoietic stem cells, and growth factors such as bone morphogenetic proteins (BMPs) that contribute to osteogenesis. Fresh frozen cancellous allograft provides an osteoconductive scaffold but lacks viable cells and growth factors. When combined with BMA, it is hypothesized to mimic the biological properties of autograft while avoiding donor site complications. Despite promising early results in few studies, there is still a paucity of comparative studies evaluating the effectiveness of BMA with allograft against autologous ICBG in managing long bone delayed unions and non-unions. This study aims to bridge that gap by prospectively comparing the clinical and radiological outcomes between these two techniques.

 
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