| CTRI Number |
CTRI/2026/01/101220 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
MRI Evaluation of Structural Factors Contributing to Patellar Instability |
|
Scientific Title of Study
|
MRI in the evaluation of factors influencing patellar instability: A structural diagnostic framework. |
| 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 Harsh Changedia |
| Designation |
Post Graduate MD Radiodiagnosis Resident |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Department of Radiodiagnosis Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
7038481121 |
| Fax |
|
| Email |
harshchangedia7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinoth Kumar |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Department of Radiodiagnosis Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
09655773100 |
| Fax |
|
| Email |
hi_hi_sandy@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinoth Kumar |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Department of Radiodiagnosis Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
09655773100 |
| Fax |
|
| Email |
hi_hi_sandy@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Vinayaka Mission Kirupananda Variyar Medical College and Hospital Salem 636308 |
| 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 Harsh Changedia |
Vinayaka Mission Kirupananda Variyar Medical College And Hospital |
Department of Radiology VMKVMCH Salem Tamilnadu 636308
Salem
TAMIL NADU |
7038481121
harshchangedia7@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 |
| Healthy Human Volunteers |
Healthy patients who are diagnosed or incidental findings as patellar instability |
| Patients |
(1) ICD-10 Condition: M235||Chronic instability of knee, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient who are willing for consent |
|
| ExclusionCriteria |
| Details |
Patient who are not willing to undergo MRI
Patient with ferromagnetic implant, pacemakers, and aneurysm clips
Patient not willing for consent and follow up
Prior knee surgery, congenital syndrome
Previously recieved intravesicular therapy, systemic chemotherapy and external beam radiotherapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Standardised the assessment of key anatomical risk factors contributing to patellar instability at the time of MRI which led to further knee related injury. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Provide a quantitative & reproducible method for evaluating patellofemoral alignment & soft tissue injury at the time of MRI. |
18 months |
|
|
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)
|
29/01/2026 |
| 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="1"
Months="8"
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
|
Patellar instability is a multifactorial condition influenced by several anatomical and structural abnormalities of the knee joint. Magnetic Resonance Imaging (MRI) plays a crucial role in the comprehensive evaluation of these factors due to its excellent soft-tissue contrast and multiplanar capability. This study focuses on the MRI assessment of key structural contributors to patellar instability, including trochlear dysplasia, patellar height abnormalities, tibial tubercle–trochlear groove (TT–TG) distance, patellar tilt, and injuries to the medial patellofemoral ligament and surrounding soft tissues. By providing a structured diagnostic framework, MRI enables accurate identification of underlying abnormalities, guides clinical decision-making, and assists in planning appropriate conservative or surgical management strategies. |