| CTRI Number |
CTRI/2025/05/086915 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Biomechanics of Knee Osteoarthritis with Total Knee replacement |
|
Scientific Title of Study
|
Kinetics,Kinematics of Gait Parameters and Functional Outcomes of Persons With Knee Osteoarthritis Undergoing Total Knee Arthroplasty - Prospective Cohort 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 |
Sowmiya M |
| Designation |
Assistant Professor |
| Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
SRM IST , Department of Physiotherapy ,Kattankulathur 603 203 , Chengalpet District
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
06369290837 |
| Fax |
|
| Email |
sowmiyam1@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shantanu Patil |
| Designation |
Director |
| Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
Directorate of Entrepreneurship & Innovation , Head, Department of Translational Medicine and Research
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7030142727 |
| Fax |
|
| Email |
shantanup@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shantanu Patil |
| Designation |
Director |
| Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
Directorate of Entrepreneurship & Innovation , Head, Department of Translational Medicine and Research
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7030142727 |
| Fax |
|
| Email |
shantanup@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER
SRM COLLEGE OF ENGINEERING LAB |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Sowmiya M |
Orthopaedics Outpatient department / Movement Analysis lab |
SRM Nagar , Potheri , Kattankulathur
Kancheepuram
TAMIL NADU |
6369290837
sowmiyam1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed case of Osteoarthritis
Patients who will undergo Total Knee Arthroplasty
Radiographically assessed OA classified according to KL grade
|
|
| ExclusionCriteria |
| Details |
Previous surgical operations on lower limb
very unstable knee before surgery
Femoral or tibial fractures are conservatively treated |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kinetics and Kinematics
Knee contact forces |
Preoperative
6 weeks after surgery
6 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oxford Knee Score |
Preoperative
After 6 weeks
After 6 months of surgery |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
02/06/2025 |
| 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="4"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Patients with osteoarthritis are categorized in to three groups, one will be given hindfoot malalignment corrective exercises , other insole will be provided and the other one is a controlled group. We will find the outcome after 24 weeks of the study. |