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CTRI Number  CTRI/2025/03/082864 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to compare results of two different surgeries for treating loss of blood supply of the femoral head in children. 
Scientific Title of Study   Comparison of radiological and functional outcome of paediatric non traumatic femoral head osteonecrosis managed by core decompression alone versus core decompression and bone marrow concentrate aspirate- a prospective pseudo-randomized study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rasim Abid Elayedatt 
Designation  Senior Resident 
Affiliation  Christian Medical College Vellore 
Address  Department of Paediatric Orthopaedics Paul Brand Building Christian Medical College Vellore Ida Scudder Road

Vellore
TAMIL NADU
632004
India 
Phone  9746209401  
Fax    
Email  rasim.elayedatt@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Thomas Palocaren 
Designation  Senior Professor Head of the Department 
Affiliation  Christian Medical College Vellore 
Address  Department of Paediatric Orthopaedics Paul Brand Building Christian Medical College Vellore Ida Scudder Road

Vellore
TAMIL NADU
632004
India 
Phone  914162282172  
Fax    
Email  thomaspalox@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Thomas Palocaren 
Designation  Senior Professor Head of the Department 
Affiliation  Christian Medical College Vellore 
Address  Department of Paediatric Orthopaedics Paul Brand Building Christian Medical College Vellore Ida Scudder Road

Vellore
TAMIL NADU
632004
India 
Phone  914162282172  
Fax    
Email  thomaspalox@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Internal - Fluid Research Grant , Christian Medical College Vellore 
 
Primary Sponsor  
Name  Internal - Fluid Research Grant  
Address  Christian Medical College Vellore, Tamil Nadu 
Type of Sponsor  Private 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 
Rasim Abid Elayedatt  Christian Medical College- Vellore  Department of Paediatric Orthopaedics,1106, First Floor, Paul Brand Building, Christian Medical College- Vellore Ida Scudder Road
Vellore
TAMIL NADU 
914162282172

paedortho@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD (IRB) OFFICE OF RESEARCH CHRISTIAN MEDICAL COLLEGE VELLORE, INDIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M873||Other secondary osteonecrosis, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Femoral Head- Core decompression  CD is an routinely performed surgical intervention for avascular necrosis of femoral head. This is not a novel procedure. 
Intervention  Femoral Head- Core decompression and Bone marrow aspirate concentrate (CD-BMAC) application  CD- BMAC is an routinely performed surgical intervention for avascular necrosis of femoral head. This is not a novel procedure.  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Diagnosis of Nontraumatic Femoral head osteonecrosis (FHO) by history, clinical examination, and MRI
Stage I to stage III osteonecrosis according to Steinberg classification
Willingness to participate and provide informed consent.
 
 
ExclusionCriteria 
Details  FHO secondary to trauma, Perthes disease, Developmental Dysplasia of Hip
Previous surgery or conservative treatment for FHO
Contraindications to Core Decompression (CD) or Bone Marrow Aspirate Concentrate (BMAC), such as infection, malignancy, or allergy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Paediatric Outcomes Data Collection Instrument (PODCI).   at pre-operative, postoperative six months, one year and two years. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the radiographic parameters, such as femoral head sphericity, caput index, joint space width, and osteonecrosis Steinberg stage.
2. Complications, such as infection, fracture, and avascular necrosis progression.
3. Improvement in outcome, using the modified Harris Hip Score (mHHS).
4. To evaluate correlation between functional and radiological outcome in each group, viz Core decompression alone and core decompression followed by bone marrow concentrate application.
5. To quantify the osteoprogenitor cells in the bone marrow aspirate and concentrate and to correlate the functional and radiological score to quality of bone marrow aspirate concentrate.
 
at pre-operative, postoperative six months, one year and two years. 
 
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   Phase 3 
Date of First Enrollment (India)   01/04/2025 
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="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  

Femoral head osteonecrosis (FHO) is a condition where the disruption of blood supply to the femoral head leads to bone death and collapse. It can result in pain, stiffness, and disability in children and adolescents. The etiology of FHO in children is diverse and includes trauma, infection, sickle cell disease, steroid use, and idiopathic factors. The treatment of FHO in children aims to preserve the femoral head shape and function and prevent or delay the need for hip replacement. One of the common surgical treatments for FHO in children is core decompression, which involves drilling a hole into the femoral head to relieve pressure and improve blood flow. Core decompression can be combined with other techniques, such as bone grafting, bone morphogenetic protein, or bone marrow concentrate aspirate (BMCA).

Non traumatic FHO- due to various etiology including SCD, other haematological conditions and children on steroid treatment, will be included in the study, only after being diagnosed to have FHO by MRI.

The FHO in these children will be classified as per Steinberg classification which indicates severity of the disease process. Among these children only those femoral heads in the pre collapse stage (Stage I-III) will be included in the study.

 

Despite the difference in etiology and the disease specific challenges, since the disease pathology (FHO) is staged as per Steinberg I-III, the baseline status of osteonecrosis as per inclusion criteria is limited to pre collapse stage of FHO.

But, in some disease conditions, children who undergo intervention in our study may still continue their medical treatment, like steroids and potentially have an effect on the conclusions in our study.

Paediatric population diagnosed to have femoral head osteonecrosis by MRI will be included in the study. They will be screened by the applying inclusion criteria and allotted by consecutive sampling into Group A and Group B, after obtaining consent. In Group A, after pre anesthetic clearance, core decompression of the femoral head will be performed, whereas in Group B, patients will undergo core decompression of the femoral head followed by application of bone marrow aspirate concentrate obtained from the ipsilateral iliac crest. Patients in both groups will have evaluation of the functional parameters, using the quality of life, clinical scoring and radiographic parameters in the pre-operative, six months, one- and two-year postoperative periods. The demographic and anthropometric parameters and complications also will be recorded.

These parameters will be compared for the Group A and Group B patients, and the result obtained will be used to infer about the safety, efficacy and advantages of the interventions.


 
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