| 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
|
|
|
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
|
|
|
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.
|