| CTRI Number |
CTRI/2024/04/065710 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the benefits of Total Hip replacement in patients with Avascular Necrosis of Femoral head |
|
Scientific Title of Study
|
Outcome analysis of Total Hip Arthroplasty in Non-traumatic Avascular necrosis of femur head |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gursimran Singh |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha |
| Address |
Orthopaedics Department Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha, Maharashtra.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9536200002 |
| Fax |
|
| Email |
simransekhon012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nareshkumar Satyanarayan Dhaniwala |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha |
| Address |
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 Nareshkumar Satyanarayan Dhaniwala |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha |
| Address |
Orthopaedics Department, Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha, Maharashtra.
MAHARASHTRA
442001
India |
| Phone |
9422188450 |
| Fax |
|
| Email |
nsdhaniwala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Orthopaedics Department, Jawaharlal Nehru medical college, Sawangi (Meghe), Wardha, Maharashtra. 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha |
| Address |
Orthopaedics Department, Jawaharlal Nehru medical 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 Gursimran Singh |
Jawaharlal Nehru Medical College |
Department of Orthopaedics, Datta meghe institute of higher education and research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA |
9536200002
simransekhon012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Operated cases of Total Hip Replacement in non-traumatic avascular necrosis of Femoral head |
|
| ExclusionCriteria |
| Details |
Unwilling patients, cases of AVN of femoral head due to trauma, cases with pre-existing pelvic pathology, cases of pre-existing lower limb defects/deformities/limb length discrepancies |
|
|
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, there might be better
clinical outcome (using Harris Hip Score) in patients managed with Total Hip Arthroplasty. |
3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
At the end of study, there might be better
radiological outcome in patients managed with Total Hip Arthroplasty. |
3 months, 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
22/04/2024 |
| 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="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
|
Outcome analysis of Total Hip Replacement in Non-Traumatic Avascular Necrosis of Hip will be done. Patients will be evaluated on bases of Harris Hip score and on radiological parameters. 25 patients will be taken up for study. They would have gone Total Hip Replacement. Harris Hip score is a clinical assessment score, whereas radiologicaly placement of acetabular cup, femoral head ans stem will be assesed. Assessment will be done post operatively after 3, 6 and 12 months. |