| CTRI Number |
CTRI/2024/02/062403 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Satisfaction after Total Knee Arthroplasty in India - Functional Outcome Analysis Study |
|
Scientific Title of Study
|
Satisfaction After Total Knee Arthroplasty In
India - Analysis Of Functional Outcomes: A Multicenter National Study
(SATISFY) |
| Trial Acronym |
SATISFY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raja Bhaskara Kanakeshwar Rajasekaran |
| Designation |
Associate Consultant |
| Affiliation |
Ganga Medical Center |
| Address |
Administration Room, 7th Floor,
B - Block,
313,314-1, Ganga Hospital,
Mettupalayam Road,
Coimbatore Administration Room, 7th Floor,
B - Block,
313,314-1, Ganga Hospital,
Mettupalayam Road,
Coimbatore Coimbatore TAMIL NADU 641043 India |
| Phone |
9994945111 |
| Fax |
|
| Email |
rajabhaskar.ortho@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Raja Bhaskara Kanakeshwar Rajasekaran |
| Designation |
Associate Consultant |
| Affiliation |
Ganga Medical Center |
| Address |
Administration Room, 7th Floor,
B - Block,
313,314-1, Ganga Hospital,
Mettupalayam Road,
Coimbatore Administration Room, 7th Floor,
B - Block,
313,314-1, Ganga Hospital,
Mettupalayam Road,
Coimbatore Coimbatore TAMIL NADU 641043 India |
| Phone |
9994945111 |
| Fax |
|
| Email |
rajabhaskar.ortho@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Raja Bhaskara Kanakeshwar Rajasekaran |
| Designation |
Associate Consultant |
| Affiliation |
Ganga Medical Center |
| Address |
Administration Room, 7th Floor,
B - Block,
313,314-1, Ganga Hospital,
Mettupalayam Road,
Coimbatore Administration Room, 7th Floor,
B - Block,
313,314-1, Ganga Hospital,
Mettupalayam Road,
Coimbatore Coimbatore TAMIL NADU 641043 India |
| Phone |
9994945111 |
| Fax |
|
| Email |
rajabhaskar.ortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Society of Knee Surgeons of India (SKI)
Sancheti Hospital, 16, Shivajinagar, Pune, Maharashtra - 411005 |
|
|
Primary Sponsor
|
| Name |
Society of Knee Surgeons of India (SKI) |
| Address |
Sancheti Hospital,
16, Shivajinagar,
Pune, Maharashtra 411005 |
| Type of Sponsor |
Other [SKI is a society of professionals involved in the management of knee diseases] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raja Bhaskara Kanakeshwar Rajasekaran |
Ganga Medical Center and Hospitals Private Limited |
Administration Room, 7th Floor,
B - Block,
313,314-1, Ganga Hospital,
Mettupalayam Road,
Coimbatore Coimbatore TAMIL NADU |
9994945111
rajabhaskar.ortho@gmail.com |
| Dr Parag K Sancheti |
Sancheti Institute for Orthopaedics and Rehabilitation |
PG College Office, Room 3,
Sancheti Hospital,
11/12 Thube Park,
16 Shivajinagar,
Pune Pune MAHARASHTRA |
8888553333
sanchetipk@gmail.com |
| Dr Shrishti Patil |
Sparsh Super speciality Hospital |
Number 146 Infantry Road, Opposite to
police commissioners office Bengaluru, Bengaluru (Bangalore) Urban,
Karnataka - 560001 Bangalore KARNATAKA |
9448122280
drshrishtipatil@sparshhospital.com |
| Dr Adarsh Reddy |
Sunshine Hospitals |
Sunshine Hospitals, Beside Paradise Hotel, PG Road, Secunderabad, Hyderabad Hyderabad TELANGANA |
9673225474
dr.adarshannapareddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sancheti Inst for Orthopaedics and Rehabilitation |
Submittted/Under Review |
| Institutional Ethics Committee, Sparsh Hospital for Advanced Surgeries |
Submittted/Under Review |
| Institutional Ethics Committee, Sunshine Hospitals |
Submittted/Under Review |
| Institutional Review Board, Ganga Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Primary Tricompartmental Osteoarthritis of Knees undergoing TKA surgery
Degenerative Osteoarthritis of Knees undergoing TKA surgery |
|
| ExclusionCriteria |
| Details |
Inflammatory arthritis of knees
Infection in the same limb
Patients not willing to participate
Unicompartmental arthritis of knee |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Satisfaction Analysis following TKA surgery |
6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Causes of dis-satisfaction following TKA surgery |
6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="20000" Sample Size from India="20000"
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)
|
01/05/2024 |
| 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="0" Months="3" 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
|
While TKA surgery has proven to alleviate pain, restore function and improve quality of life in patients with advanced degenerative arthritis of the knee, a sizable portion of the population is dissatisfied with their outcome. Numerous papers, mainly from the West, have shown this cohort to be about 18%. Factors such as associated low back pain, history of mental health problems, use of a fixed-bearing insert, and poor post-operative function have been shown to influence post-surgery outcomes negatively. However, most of these data are from western developed countries, and very few are from developing countries like India. Many factors are variable in patients from India who undergo TKA compared with patients from the West. Unlike the West, where a central healthcare system governs the modalities and delivery of healthcare, India has a multi-payer healthcare model paid for by a combination of private and public health insurance funds. Hence the factors responsible for dissatisfaction will be different for patients from India. Unlike the West, only 18% of total outpatients and 44% of inpatient care are in the public health sector. Variation in utilization of services across of the country also results in wide practice preferences among surgeons in surgeries like TKA.
Analysis of satisfaction outcomes following in TKA in India on a national scale will enable researchers analyse causes of dis-satisfaction, and also aim to improve outcomes in future. This multicentre observational study will help us analyse the satisfaction following TKA, across India. |