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CTRI Number  CTRI/2025/08/092984 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Single Arm Study 
Public Title of Study   How Knee Osteoarthritis is being Treated In a Teaching Hospital 
Scientific Title of Study   Treatment Patterns of Knee Osteoarthritis in a Tertiary Care Teaching Hospital: A Retrospective 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  Abdul Jishad 
Designation  PG Student 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department Of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7025518702  
Fax    
Email  jishad5518@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRoopa Satyanarayan  
Designation  Assisstant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department Of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  DrRoopa Satyanarayan  
Designation  Assisstant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department Of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University), Paneer, Deralakatte, Mangaluru, India 575018 
 
Primary Sponsor  
Name  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University), Paneer, Deralakatte, Mangaluru, India 575018 
Type of Sponsor  Other [Academic Institute] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Roopa Satyanarayan  Justice K.S Hegde Charitable Hospital  Department of Orthopaedics Medical records department
Dakshina Kannada
KARNATAKA 
9047155003

roopa.satyanarayan@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee ( NGSMIPS- IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Knee Osteoarthritis Patient, aged Greater Than 40 Years 
 
ExclusionCriteria 
Details  Pregnant Women
Incomplete Data Files
Inflammatory Arthritis
Patients with both hip and knee Osteoarthritis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of pharmacological and non pharmacological treatments  8 months 
 
Secondary Outcome  
Outcome  TimePoints 
age
gender
number of comorbidities
Charlson comorbidity Index
 
8 Months 
 
Target Sample Size   Total Sample Size="720"
Sample Size from India="720" 
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)   26/08/2025 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

INTRODUCTION:  Osteoarthritis  is a slowly developing progressive disorder that causes the breakdown of cartilage, malfunction of subchondral bone and disturbances in the efficiency of synovial fluid. It is the leading cause of chronic pain and lower extremity disabilities, especially in elderly people. Knee joints is the most commonly affected.

NEED FOR THE STUDY : Knee Osteoarthritis treatment pattern  helps to evaluate the pharmacological and non pharmacological  treatments. It ensures the rational drug use. This data can be helpful in   formulating health care policies and improving the prescribing behavior of clinician. It helps to reduce the risk of drug interaction and improve medication safety.

OBJECTIVES : 

 To assess  the treatment patterns among knee osteoarthritis patients.

 To determine the factors associated with risk of intra-articular steroid injection in knee Osteoarthritis.

METHODOLOGY : A retrospective observational  study  is conducted for 8 months duration. Patients with  greater than and equal to 40 years age with knee osteoarthritis having ICD code of M17. Patients who took admissions on different years, their latest admission will be considered for the study. The data will be collected from medical records department. Ethics committee permission will be obtained before the study.

STATISTICAL ANALYSIS  : The data will be summarized using descriptive statistic that is mean plus SD or frequency percentage .The data will be analyzed using the SSPS software version  29.0.

OUTCOME MEASURES : The primary outcome measure includes identifying the  number of Pharmacological & non  pharmacological treatments. The secondary outcome measures include, identifying demographic characteristics, number of comorbidities  and comorbidities  present.


 
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