| 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
|
|
|
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
|
|
|
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. |