| CTRI Number |
CTRI/2024/11/076369 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the size of each quadriceps muscle using ultrasound in participants with osteoarthritic knee and those of the same age without the condition. |
|
Scientific Title of Study
|
Correlation of Age Matched Osteoarthritic Populations’
Quadriceps muscle’s Cross Sectional Area by Ultrasonographic evaluation: An Observational study
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANAND HEGGANNAVAR |
| Designation |
Professor and Head of Department of Orthopedic Manual Therapy |
| Affiliation |
Kle Institute Of Physiotherapy Belagavi |
| Address |
Advanced Physiotherapy centre,OPD No39,Department of Orthopedic Manual Therapy,Room no 13,Sagar Floor KLEs Dr Prabhakar Kore Hospital and MRC Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
994528296 |
| Fax |
|
| Email |
anandheggannavar@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
ANAND HEGGANNAVAR |
| Designation |
Professor and Head of Department of Orthopedic Manual Therapy |
| Affiliation |
KLE institute Of Physiotherapy Belagavi |
| Address |
Advanced Physiotherapy centre,OPD No39,Department of Orthopedic Manual Therapy,Room no 13,Sagar Floor KLEs Dr Prabhakar Kore Hospital and MRC Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
994528296 |
| Fax |
|
| Email |
anandheggannavar@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jiya Mehta |
| Designation |
Intern |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy centre,OPD No:39,Department of Orthopedic Manual Therapy,Room no :18,Sagar Floor KLEs Dr Prabhakar Kore Hospital and MRC Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8432840044 |
| Fax |
|
| Email |
jmmehta2901@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr. Prabhakar Kore Hospital and Medical Research Centre ,Belagavi ,Karnataka ,India 590010 |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar,
Belagavi-590010 |
| 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 |
| Anand Heggannavar |
KLEs Dr. Prabhakhar Kore Hospital & Medical Research Centre |
Advanced Physiotherapy centre,OPD No 39,Department of Orthopedic Manual Therapy,Room no 18,Sagar Floor KLEs Dr Prabhakar Kore Hospital and MRC Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
994528296
anandheggannavar@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee of KLEU Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Osteoarthritis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with confirmatory diagnosis of osteoarthritis (grade 1,2 & 3) using key radiological features of osteoarthritis described by Kellgren and Lawrence. |
|
| ExclusionCriteria |
| Details |
1.Patients with history of recent surgeries like knee replacement, menisci tear, ACL repair/injury.
2.Patient suffering from cancer, Pregnant women, Infection.
3.Individuals with Metal implant, Pacemaker etc.
4.Individuals with structural knee conditions like genu varum/ valgum, genu recurvatum.
Patients unwilling to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cross sectional area of individual quadriceps muscle using Ultrasonagraphy |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2024 |
| Date of Study Completion (India) |
20/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Osteoarthritis is a degenerative joint condition that causes pain,swelling ,and stiffness ,and affects a persons ability to move freely .We are conducting a study on correlation of cross sectional area of each quadriceps muscle in osteoarthritic knee with age matched population using ultrasonography This study will be conducted on age group between 45-64 years with grade 1,2 ,3 Osteoarthritis knee The benefits of this study is to determine the weakness in each quadricep muscle correlated to cross sectional area in osteoarthritic patients |