| CTRI Number |
CTRI/2026/02/104018 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Use of smartphone applications to increase the accuracy of acetabular cup placement during total hip replacement |
|
Scientific Title of Study
|
Use of smartphone applications to increase the accuracy of acetabular cup placement during 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 |
Dr RAJAT GUPTA |
| Designation |
Professor |
| Affiliation |
ESI-PGIMSR, Basaidarapur, New Delhi |
| Address |
Professor, Department of Orthopaedics, ESI-PGIMSR, Basaidarapur, New Delhi
West
DELHI
110015
India |
| Phone |
9810162593 |
| Fax |
|
| Email |
drrajatgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAJAT GUPTA |
| Designation |
Professor |
| Affiliation |
ESI-PGIMSR, Basaidarapur, New Delhi |
| Address |
Professor, Department of Orthopaedics, ESI-PGIMSR, Basaidarapur, New Delhi
DELHI
110015
India |
| Phone |
9810162593 |
| Fax |
|
| Email |
drrajatgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukul Mittal |
| Designation |
Junior Resident |
| Affiliation |
ESI-PGIMSR, Basaidarapur, New Delhi |
| Address |
Department of Orthopaedics, ESI-PGIMSR, Basaidarapur, New Delhi
West
DELHI
110015
India |
| Phone |
9958444107 |
| Fax |
|
| Email |
mukulmittal313@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI-PGIMSR, Basaidarapur, New Delhi - 110015 |
|
|
Primary Sponsor
|
| Name |
ESIPGIMSR Basaidarapur New Delhi |
| Address |
ESI-PGIMSR, Basaidarapur, New Delhi, India 110015 |
| Type of Sponsor |
Government 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 Mukul Mittal |
ESI-PGIMSR |
Department of Orthopaedics,ESI-PGIMSR, Basaidarapur, New Delhi
West
DELHI |
9958444107
mukulmittal313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, ESI-PGIMSR, BASAIDARAPUR, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
compare the accuracy of acetabular cup placement via smartphone applications and free hand technique using post operative radiographs |
compare the accuracy of acetabular cup placement via smartphone applications and free hand technique using post operative radiographs |
| Intervention |
Dr. Mukul Mittal |
Using Angulus and Measure applications available in iphone, we will measure the angle of inclination and angle of anteversion of acetabular cup placement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary elective total hip arthroplasty.
2. Patients requiring cemented or uncemented THA.
3. Patients with diagnosis of hip osteoarthritis, avascular necrosis, rheumatoid arthritis, or fracture neck of femur requiring THA.
4. Patient willing to be a part of the study by giving due informed consent.
5. Patients who are declared fit for appropriate anaesthesia by the department of anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients requiring Revision THA
2. Patients with prior surgeries around the hip that could alter pelvic anatomy.
3. Patients with fracture acetabulum, protrusion acetabulum, hip dysplasia and ankylosis hip
4. Patients requiring acetabular reconstruction or augmentation
5. Tumors, or severe deformities involving the pelvis or proximal femur.
6. Intraoperative complications that alter the planned procedure (e.g., unanticipated fractures).
7. Patients with neuromuscular conditions affecting hip joint stabilty.
8. Inability to undergo follow-up imaging, or poor-quality images unsuitable for angle measurement.
9. Lack of compliance or withdrawal of consent during the study period. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the acetabular cup placement during total hip arthroplasty using smartphone applications and free hand technique |
Immediate post operratively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the accuracy of acetabular cup placement in the two groups
2. To correlate the intra-operative angles with post operative radiographic outcome. |
Immediate post operatively using Non contrast computed tomography scan of the hip |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2026 |
| 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="1"
Months="5"
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mukulmittal313@gmail.com].
- For how long will this data be available start date provided 01-10-2025 and end date provided 01-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
I wish to undertake a project entitled use of smartphone applications to increase the accuracy of acetabular cup placement during total hip arthroplasty. The research aiims to improve the accuracy of acetabular cup placement during total hip arthroplasty as the positioning of the cup is a vital part of the operative procedure and not many techniques are available. Most of the surgeons just use free hand technique for the placement of the cup which is very subjective. With this project we can develop a cheap, accurate and easy to use technique for the positioning of the acetabular cup during total hip arhtroplasty. |