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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.
 
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