| CTRI Number |
CTRI/2022/01/039187 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
04/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of MRI of knee joint injury with ultrasound findings. |
|
Scientific Title of Study
|
ULTRASONOGRAPHIC ASSESSMENT OF KNEE JOINT PATHOLOGIES WITH MRI CORRELATION. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOHANVEER SINGH |
| Designation |
PRIMARY DNB RESIDENT |
| Affiliation |
MAX SUPER SPECIALITY HOSPITAL,SHALIMAR BAGH, NEW DELHI |
| Address |
MAX SUPER SPECIALITY HOSPITAL,SHALIMAR BAGH NEW DELHI
North West
DELHI
110088
India |
| Phone |
8077003166 |
| Fax |
|
| Email |
DRSOHANVEERTATRAN@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPrerna Garg |
| Designation |
Consultant |
| Affiliation |
MAX SUPER SPECIALITY HOSPITAL,SHALIMAR BAGH |
| Address |
MAX SUPER SPECIALITY HOSPITAL,SHALIMAR BAGH NEW DELHI
New Delhi
DELHI
110088
India |
| Phone |
9654546636 |
| Fax |
|
| Email |
findprerna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SOHANVEER SINGH |
| Designation |
PRIMARY DNB RESIDENT |
| Affiliation |
MAX SUPER SPECIALITY HOSPITAL,SHALIMAR BAGH, NEW DELHI |
| Address |
MAX SUPER SPECIALITY HOSPITAL,SHALIMAR BAGH NEW DELHI
DELHI
110088
India |
| Phone |
8077003166 |
| Fax |
|
| Email |
DRSOHANVEERTATRAN@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| MAX SUPER SPECIALITY HOSPITAL SHALIMAR BAGH |
|
|
Primary Sponsor
|
| Name |
RADIOLOGY DEPARTMENT |
| Address |
MAX SUPER SPECIALITY HOSPITAL SHALIMAR BAGH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SOHANVEER |
MAX SUPER SPECIALITY HOSPITAL,SHALIMAR BAGH |
DEPARTMENT OF RADIO DIAGNOSIS , MRI/ULTRASOUND ROOM
GROUND FLOOR
North West
DELHI |
8077003166
DRSOHANVEERTATRAN@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAX HEALTHCARE ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
KNEE PAIN ,SWELLING,INSTABILITY,AND STIFFNESS |
|
| ExclusionCriteria |
| Details |
ANY DISEASE/REASON CONTRAINDICATION FOR MRI
KNEE SURGERY OF ANY KIND
FRACTURE OF FEMUR/TIBIA/FIBULA |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparing sensitivity and specificity of ultrasonography with mri |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to depict tendinous and menisco-ligamentous conditions of knee joint visible on ultrasound |
duration 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)
|
05/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/01/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial is comparative study of Ultrasongraphy with MRI for assessing knee joint tendon and ligament. |