| 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
|
|
|
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
|
|
|
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. |