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CTRI Number  CTRI/2014/09/005038 [Registered on: 19/09/2014] Trial Registered Retrospectively
Last Modified On: 12/02/2015
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Knee Osteoarthritis care in India 
Scientific Title of Study   India-based Knee Osteoarthritis Evaluation  
Trial Acronym  iKare 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Gurava Reddy  
Designation  Orthopedic surgeon 
Affiliation  Sunshine Hospitals 
Address  Dept of Orthopedics, Sunshine Hospitals, Penderghast Road Secunderabad-03 AP India

Hyderabad
ANDHRA PRADESH
500003
India 
Phone    
Fax    
Email  guravareddy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gurava Reddy 
Designation  Orthopedic surgeon 
Affiliation  Sunshine hospitals 
Address  Dept of Orthopedics, Sunshine Hospitals, Penderghast Road Secunderabad-03 AP India

Hyderabad
ANDHRA PRADESH
500003
India 
Phone    
Fax    
Email  guravareddy@gmail.com  
 
Source of Monetary or Material Support  
Moximed 26460 Corporate Ave, Hayward, CA 94545, United States  
 
Primary Sponsor  
Name  Moximed Inc 
Address  26460 Corporate Ave, Hayward, CA 94545, United States 
Type of Sponsor  Other [Designs knee implants] 
 
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 Vijay D Shetty  LH Hiranandani Hospital  Department of Orthopedics, Dr L H Hiranandani Hospital, Hill Side Avenue, Hiranandani Gardens, Powai, Mumbai (400 076)
Mumbai
MAHARASHTRA 		 999999999999999

vijaydshetty@gmail.com 
Dr Mandeep Dhillon  Post Graduate Institute of Medical Education and Research  Ground Floor, Block-B, Nehru Hospital, Dept of Orthopaedics Sector 12 Chandigarh, 160012 Punjab, India
Chandigarh
CHANDIGARH 		 919815951090

drdhillon@gmail.com 
Dr Parag Sancheti  Sancheti Institute for Orthopedics and Rehabilitation  16, Shivajinagar Pune – 411 005 Maharashtra, India
Pune
MAHARASHTRA 		 912025536262

sanchetipk@yahoo.com 
Dr Gurava Reddy  Sunshine Hospitals  Dept of Orthopedics, Penderghast Road Secunderabad-03 AP India
Hyderabad
ANDHRA PRADESH 		 040445500000

guravareddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Dr LH Hiranandani Hospital  Approved 
Institute Ethics Committee  Approved 
Institutional Ethics Committee Sunshine Hospitals  Approved 
Institutional Review Board Services  Approved 
Sancheti Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Knee pain, suspected knee osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients 18 years of age or older who present to a recruiting hospital for treatment of knee pain will be eligible for participation. The subjects must be able to understand and complete the questionnaire, and must agree to participate in the study.
 
 
ExclusionCriteria 
Details   A history of total knee replacement in the affected knee.
 An open wound or evidence of recent surgery in the affected knee.
 A current or history of tumour in the affected knee or proximal skeletal structure.
 A current or history of fracture in the tibial plateau, femoral condyle or patella.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study aims to characterize the following: general demographics of patients presenting with knee pain, severity of knee symptoms at time of presentation, severity of knee pathology at time of presentation, factors associated with decision to seek medical care, previous treatments and health care contacts, planned treatment, and gaps in treatment perceived by the patient and treating surgeons  One-time questionnaire completed by the patient and the treating surgeon 
 
Secondary Outcome  
Outcome  TimePoints 
Addressed in primary outcome description (observational study so several factors of interest).  N/A one time cross-sectional 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   13/02/2014 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

This trial was terminated due to funding constraints. At the time of termination there were 714 patients enrolled.



The objective of this cross-sectional study is to examine and describe the challenges that patients experience when undergoing treatment for knee osteoarthritis in India.  This will allow us to obtain a better description and understanding of the “treatment gap” that patients with early knee osteoarthritis are experiencing in India.  We will characterize patients and the treatments utilized for orthopaedic patients presenting to both private and public hospital centers in India with knee pain and symptoms suggestive of knee arthritis.  Specifically, we will describe the following;

  1. General demographics of patients presenting with knee pain

  2. Severity of knee symptoms at time of presentation

  3. Severity of knee pathology at time of presentation

  4. Factors associated with decision to seek medical care

  5. Previous treatments and health care contacts 

  6. Planned treatment

  7. Gaps in treatment perceived by the patient and treating surgeons

 
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