| CTRI Number |
CTRI/2026/01/100515 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on sinking of femur bone implant in patients undergoing total hip replacement for the first time |
|
Scientific Title of Study
|
Subsidence of uncemented femoral stem in primary total hip arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vibhav Vinay Deshmukh |
| Designation |
Resident doctor |
| Affiliation |
Datta meghe institue of higher education |
| Address |
Department of Orthopedics, Acharya Vinobha Bhave Rural Hospital, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9820199690 |
| Fax |
|
| Email |
drvibhavdeshmukh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Narendra Samal |
| Designation |
Consultant Professor |
| Affiliation |
Datta meghe institue of higher education |
| Address |
Department of Orthopedics, Acharya Vinobha Bhave Rural Hospital, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9820199690 |
| Fax |
|
| Email |
nitinsamal2486@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vibhav Vinay Deshmukh |
| Designation |
Resident doctor |
| Affiliation |
Datta meghe institue of higher education |
| Address |
Department of Orthopedics, Acharya Vinobha Bhave Rural Hospital, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Sawangi Meghe, Wardha 442107, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9820199690 |
| Fax |
|
| Email |
drvibhavdeshmukh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopedics, Acharya Vinobha Bhave Rural Hospital, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Sawangi (Meghe), Wardha- 442107, Maharashtra |
| 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 Vibhav Deshmukh |
Acharya Vinoba Bhave Rural Hospital |
Department of Orthopedics, Acharya Vinobha Bhave Rural Hospital, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha 442001
Wardha
MAHARASHTRA |
98201996990
drvibhavdeshmukh@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: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
osteoarthritis
avascular necrosis
mild to moderate hip dysplasia
indian origin
preoperative Harison Hip Score less than 50
6 months post operative follow up |
|
| ExclusionCriteria |
| Details |
cemented stem
revision total hip arthroplasty
hybrid fixation
severe hip dysplasia
prior hip osteotomy
infection
neoplasia
metabolic bone disease
inadequate radiographic quality for subsidence measurement
varus stem alignment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to measure early femoral stem subsidence using standardized radiographic methods and correlate extent of subsidence with early clinical outcomes including pain, function and need for revision surgery |
to measure early femoral stem subsidence using standardized radiographic methods and correlate extent of subsidence with early clinical outcomes including pain, function and need for revision surgery at post operative day 2, 1 month, 3 month, 6 months post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/01/2026 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drvibhavdeshmukh@gmail.com].
- For how long will this data be available start date provided 25-11-2025 and end date provided 25-06-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - No
|
|
Brief Summary
|
The thesis titled “Subsidence of Uncemented Femoral Stem in Primary Total Hip Arthroplasty” by Dr. Vibhav Deshmukh under the guidance of Dr. Nitin Samal investigates early femoral stem subsidence in uncemented total hip arthroplasty (THA) and its impact on clinical outcomes. Conducted as an observational cohort study at Acharya Vinoba Bhave Rural Hospital, Wardha, the research aims to measure early postoperative femoral stem subsidence using radiographic and clinical assessments over one year. The study explores correlations between stem migration and factors such as age, BMI, implant design, and surgical alignment, with outcomes measured by radiographs and the Modified Harris Hip Score. It emphasizes early weight-bearing rehabilitation, reviews global and Indian data on THA subsidence rates, and seeks to identify predictive factors to improve surgical planning, implant selection, and patient-specific rehabilitation protocols for better postoperative stability and satisfaction in uncemented THA patients |