| CTRI Number |
CTRI/2024/05/067050 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Investigating Surgical Approaches for Preserving the Femoral Head in Avascular Necrosis: An In-depth Examination |
|
Scientific Title of Study
|
A Study on Surgical Strategies for Conservation of Femoral head in Avascular Necrosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Shrivastava |
| Designation |
Director Professor |
| Affiliation |
|
| Address |
Department of Orthopaedics Acharya Vinoba Bhave Rural Hospital Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09765404068 |
| Fax |
|
| Email |
ceohospitals@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Shrivastava |
| Designation |
Director Professor |
| Affiliation |
|
| Address |
Department of Orthopaedics Acharya Vinoba Bhave Rural Hospital Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09765404068 |
| Fax |
|
| Email |
ceohospitals@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Shrivastava |
| Designation |
Director Professor |
| Affiliation |
|
| Address |
Department of Orthopaedics Acharya Vinoba Bhave Rural Hospital Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09765404068 |
| Fax |
|
| Email |
ceohospitals@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital Sawangi |
|
|
Primary Sponsor
|
| Name |
Dr Sandeep Shrivastava |
| Address |
DMIHER JNMC Campus Sawangi Wardha |
| 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 Sandeep Shrivastava |
Acharya Vinoba Bhave Rural Hospital |
Department of Orthopaedics Datta Megha Institute of Higher Education and Research Center Sawangi Wardha
Wardha
MAHARASHTRA |
9765404068
ceohospitals@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DMIHER DU |
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 |
| Comparator Agent |
Core decompression with BMAC, Core Decompression with Reverse Bone grafting and BMAC infiltration, Internal Engineering with BMAC infiltration |
Core decompression by creation of with 6-8 mm size tunnel or multiple drilling of the sclerotic head and BMAC infiltration, Core Decompression and bone grafting by Reverse bone grafting technique and BMAC infiltration, Internal engineering Technique and BMAC infiltration |
| Intervention |
Core decompression with PRP, Core Decompression with Reverse Bone grafting and PRP infiltration, Internal Engineering with PRP infiltration |
Core decompression by creation of with 6-8 mm size tunnel or multiple drilling of the sclerotic head and PRP infiltration, Core Decompression and bone grafting by Reverse bone grafting technique and PRP infiltration, Internal engineering Technique and PRP infiltration |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Asymptomatic/Symptomatic patients who have less or approximately 50% loss of sphericity of the head of the femur due to avascular necrosis |
|
| ExclusionCriteria |
| Details |
AVN of the Head involving more than 50% of structural defect/ collapse and severe loss of sphericity with established osteoarthritis of the Hip
Previously undergone any surgery of Hip for Avascular necrosis like – Muscle pedicle grafts /fibular grafting |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To test the different protocols of surgical interventions along with regenerative medicine interventions to conserve the femoral head in avascular necrosis. |
Pre-op, 1-10 days, 16-20 weeks, 36-40 weeks, 2 years and 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reversal Of Avascular Necrosis of Femoral head |
5 years |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
What is the efficacy and feasibility of a three different surgical treatment protocol towards conservation of femoral head in avascular necrosis of the hip, in terms of patient outcomes, functional recovery, and long-term success? To test the different protocols of surgical interventions along with regenerative medicine interventions to conserve the femoral head in avascular necrosis. |