| CTRI Number |
CTRI/2023/09/057253 [Registered on: 05/09/2023] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression |
|
Scientific Title of Study
|
Randomized control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Lohiya |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research ,Sawangi Meghe, Wardha |
| Address |
Room no. F-1 , Raghobaji PG boys hostel, Orthopaedics department, Jawaharlal Nehru Medical College, Sawangi(Meghe) , Wardha, Maharashtra.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9959565759 |
| Fax |
|
| Email |
ashutoshlohiya2011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Dhaniwala |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research ,Sawangi Meghe, Wardha |
| Address |
Flat no. 2 , ground floor , Meghdoot apartments , Orthopaedics department, Jawaharlal Nehru Medical College, Sawangi(Meghe) , Wardha, Maharashtra.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422188450 |
| Fax |
|
| Email |
nsdhaniwala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Lohiya |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research ,Sawangi Meghe, Wardha |
| Address |
Room no. F-1 , Raghobaji PG boys hostel, Orthopaedics department, Jawaharlal Nehru Medical College, Sawangi(Meghe) , Wardha, Maharashtra.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9959565759 |
| Fax |
|
| Email |
ashutoshlohiya2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Orthopaedics Department, Jawaharlal Nehru Meical College, Sawangi Meghe , Wardha Maharashtra 442001 |
| 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 |
| Dr Ashutosh Lohiya |
Jawaharlal Nehru Medical College |
Department of
Orthopaedics
,Sawangi(Meghe) , Wardha , Maharashtra
Wardha
MAHARASHTRA |
9959565759
ashutoshlohiya2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
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 |
Core decompression |
Core decompression - reduces the elevated intraosseous pressure in the femoral head leading to increased blood flow thereby promoting new bone formation and healing. Less surgical time |
| Comparator Agent |
Core decompression and Bisphosphonate therapy |
Bisphosphonates inhibits the osteoclastic activity in the osteonecrotic lesion site, thus promoting bone healing . Delays in necrosis of bone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1. Skeletally mature patients
2. Cases of Avascular Necrosis of femoral head in stage 1 and stage 2 of any etiology
3. Cases willing to undergo surgery for inclusion in one / both hips .
|
|
| ExclusionCriteria |
| Details |
1. Previously operated hips
2. Cases having arthritic changes in involved hip
3. Cases unwilling for surgery
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of study , their might be probable improvement in Patients managed with Core decompression with bisphosphonate therapy for the treatment of early AVN of the femoral head when compared to management with core decompression only |
3 weeks , 6 weeks , 3 months , 6 months , 9 months , 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
10/09/2023 |
| 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 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
|
Patients coming to OPD with Pain over hip joint will be subjected to history and clinical examination . on suspicion of
Avascular Necrosis of Femoral Head(AVNFH) radiological assessment of pelvis with
X-ray and MRI will be carried out. After proper staging of AVNFH , stage I and
II cases will be explained the disease and nature of treatment . on written informed
consent they will be allocated to one group by simple randomization 1,3,5,7,
….. to core decompression with bisphosphonate therapy and 2,4,6, …. To core
decompression alone . Patients were also grouped based on their etiological
factors causing AVN. Patients will then be subjected to routine
blood investigations and fitness for surgery was obtained while doing core
decompression .
A). Clinical data obtained from the patient was noted in a pre-printed
forms based on
following parameters like Age, Sex, risk factors, duration of the illness
and physical
assessments (Pain –VAS score, Range of Motion and deformity) and Harris Hip score.
B). Radiological Data was obtained at the time of first presentation:
- X-ray AP pelvis with Both hip and Lateral view of affected hip
- MRI pelvis with both hip along with FICAT-ARLET classification
C). Laboratory Data:-Inflammatory parameters-ESR, CRP,
Coagulation Profile - APTT, PT-INR, BT, CT, CBC, Prothrombin time, platelet count
Others- LFT, KFT
Thereafter patients were posted for surgical intervention and treatment
as per protocol |