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
|
|
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
|
|
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. |