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CTRI Number  CTRI/2017/08/009480 [Registered on: 24/08/2017] Trial Registered Retrospectively
Last Modified On: 18/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Three different modalities of treatment for osteoarthritis knee in eastern Indian population. 
Scientific Title of Study   A comparative study of the results of Conservative therapy, Intra articular steroid injection therapy and intra articular haluronic acid injection therapy in primary osteoarthritis of knee. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Wanlamkupar Khongwir 
Designation  Senior Resident Doctor 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences 
Address  Department of Orthopaedics NEIGRIHMS Room no 3 Mawdiangdiang
kenches trace near mgcc building shillong-793008
East Khasi Hills
MEGHALAYA
793014
India 
Phone  8013055428  
Fax    
Email  khongwirwanlam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Subhasish Saha 
Designation  head of department orthopaedics 
Affiliation  medical college kolkata 
Address  Green Building, 2 floor Department of Orthopaedics Medical College Kolkata 88,College Street

Kolkata
WEST BENGAL
700073
India 
Phone  8013055428  
Fax    
Email  subhasishsaha@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Wanlamkupar Khongwir 
Designation  Senior Resident Doctor 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences 
Address  Department of Orthopaedics NEIGRIHMS Room no 3 Mawdiangdiang

East Khasi Hills
MEGHALAYA
793014
India 
Phone  8013055428  
Fax    
Email  khongwirwanlam@gmail.com  
 
Source of Monetary or Material Support  
Green Building, 2 floor Department of Orthopaedics Medical College Kolkata 88,College Street 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Wanlamkupar Khongwir  kolkata medical college  Green building, 2 floor Department of Orthopaedics Kolkata medical college 88,college street
Kolkata
WEST BENGAL 
8013055428

khongwirwanlam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ehics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patient with primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Three different modalities of treatment for osteoarthritis knee in eastern Indian population.  In Conservative therapy ( physiotherapy and NSAIDS), intra-articular Steroid injection therapy ( we use methylprednisolone 80mg single injection) and intra -articular Hyaluronic acid injection therapy ( 2ml (20mg) 5 weekly injection. follow up every 2,4 and 6 months. during follow up results are compare using WOMAC knee score and Lequesne osteoarthritis score. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient above 40 years with primary osteoarthritis of knee including both male and female. 
 
ExclusionCriteria 
Details  Age below 40 years.
1.Pain in knee after trauma.
2.Local infections in and around knee joint.
3.Uncontrolled diabetes mellitus.
4.Severe joint deformity.
5.Patient on anticoagulant therapy and allergies to avian products.
6.Patient with history of surgery in and around the knee.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The results from our study suggests that Corticosteroids are more effective than Hyaluronic acid in the short term (2 months), whereas Hyaluronic acid is more effective in the long term (2nd month upto 4th month). In case of patients undergoing conservative therapy there is no much significance improvement.   Follow up is done at 2 months,4 months and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2013 
Date of Study Completion (India) 31/03/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none (0) 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The objective of the study is to compare the results of conservative therapy, intra articular steroid injection therapy and intra articular hyaluronic acid injection therapy in primary osteoarthritis of knee. Our study is a prospective study which includes a total of 45 patients receiving the above treatment. All the patients were followed for upto 6 months. We did not loss any patients in the follow up.

In summary, the results from our study suggests that corticosteroids are more effective than hyaluronic acid in the short term (2 months), whereas hyaluronic acid is more effective in the long term (2nd  month upto  4th  month). In case of patients undergoing conservative therapy there is no much significance improvement.  Awareness of this pattern of response is useful to the clinician in formulating a therapeutic plan for patients with knee OA. 

 
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