CTRI Number |
CTRI/2020/03/024397 [Registered on: 31/03/2020] Trial Registered Prospectively |
Last Modified On: |
31/03/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Comparison of the effect of three drugs injected in the knee joint for age-related knee degeneration |
Scientific Title of Study
|
A multi-arm double-blinded randomized controlled study to compare intra-articular ketorolac, hyaluronic acid and steroid for knee osteoarthritis |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Vivek Tiwari |
Designation |
Assistant Professor, Department of Orthopaedics |
Affiliation |
AIIMS Nagpur |
Address |
Department of Orthopaedics, AIIMS, Plot No. 2, Sector 20, MIHAN, Nagpur
Nagpur MAHARASHTRA 441108 India |
Phone |
|
Fax |
|
Email |
drvivektiwari@aiimsnagpur.edu.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vivek Tiwari |
Designation |
Assistant Professor, Department of Orthopaedics |
Affiliation |
AIIMS Nagpur |
Address |
Department of Orthopaedics, AIIMS, Plot No. 2, Sector 20, MIHAN, Nagpur
MAHARASHTRA 441108 India |
Phone |
|
Fax |
|
Email |
drvivektiwari@aiimsnagpur.edu.in |
|
Details of Contact Person Public Query
|
Name |
Dr Samir Dwidmuthe |
Designation |
Associate Professor, Department of Orthopaedics |
Affiliation |
AIIMS Nagpur |
Address |
Department of Orthopaedics, AIIMS, Plot No. 2, Sector 20, MIHAN, Nagpur
Nagpur MAHARASHTRA 441108 India |
Phone |
|
Fax |
|
Email |
samirdwidmuthe@aiimsnagpur.edu.in |
|
Source of Monetary or Material Support
|
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India (Applied for Funding) |
|
Primary Sponsor
|
Name |
ICMR |
Address |
AIIMS Campus Temple, ANSARI NAGAR, NEAR, GATE NO.2, New Delhi, 110029 |
Type of Sponsor |
Government funding agency |
|
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 Vivek Tiwari |
All India Institute of Medical Sciences, Nagpur |
Department of Orthopaedics, Room No. 214, OPD Block, All India Institute of Medical Sciences, Plot No. 2, Sector 20, MIHAN, Nagpur Nagpur MAHARASHTRA |
9868633097
drvivektiwari@aiimsnagpur.edu.in |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethics Committee AIIMS Nagpur |
Approved |
Institutional Ethics Committee AIIMS Nagpur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Ketorolac intra-articular injection for knee osteoarthritis |
In this randomized controlled double-blinded study, intra-articular injections will be given for symptomatic knee osteoarthritis patients. 30 patients each will be enrolled in the three groups – steroid, hyaluronic acid and ketorolac. Patients will be followed-up at 2 weeks, 6 weeks, 3 months and 6 months to assess pain relief using VAS, functional outcome using WOMAC score, KSS and SF-36 score, as well as patient satisfaction on a 5-point Likert scale. |
Comparator Agent |
Steroid intra-articular injection for knee osteoarthritis, Hyaluronic acid intra-articular injection for knee osteoarthritis |
In this randomized controlled double-blinded study, intra-articular injections will be given for symptomatic knee osteoarthritis patients. 30 patients each will be enrolled in the three groups – steroid, hyaluronic acid and ketorolac. Patients will be followed-up at 2 weeks, 6 weeks, 3 months and 6 months to assess pain relief using VAS, functional outcome using WOMAC score, KSS and SF-36 score, as well as patient satisfaction on a 5-point Likert scale. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
1. Patients with symptomatic knee osteoarthritis with K-L grade 2 or 3 on X-ray.
2. Patients willing to participate in the study and ready for 6 months follow-up. |
|
ExclusionCriteria |
Details |
1. Prior injections into the same knee within the last 1 year
2. Failure of past treatment with corticosteroid injections
3. Medical treatment including oral medication, physical therapy, or other analgesia use within the last one month prior to injection
4. Pregnant/Lactating women
5. Age <18 years
6. Serious systemic disease
7. Gout arthropathy
8. Inflammatory joint disease including rheumatoid or psoriatic arthritis
9. Known hypersensitivity to the contents of the drugs
10. Patients with a significant effusion that requires aspiration
11. Patients with previous history of any surgery to the same knee
12. Secondary osteoarthritis |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
VAS score |
2 weeks, 6 weeks, 3 months and 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Knee Function assessed using WOMAC, KSS and SF-36 scores
2. Patient satisfaction using 5-point Likert scale |
3 months and 6 months |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
30/04/2020 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Background: Knee osteoarthritis (OA) has become an important and disabling issue worldwide as the life expectancy has increased due to availability of better medical facilities, with a rise in the proportion of elderly population. Intra-articular injections provide a good treatment option for pain relief and disability limitation for a sizable number of patients who are not getting benefit from medicines and physiotherapy, but who are not willing for surgical management or who are not fit for surgery. Novelty: Ketorolac has been described as a new, cost-effective and safe option for intra-articular injections for knee OA, but there has not been any comparative study of intra-articular ketorolac with the well-described and used option – intra-articular steroid. Objectives: Is the pain relief (as scored by VAS score) at 2 weeks, 6 weeks, 3 months and 6 months; functional outcome provided at 6 months and patient satisfaction at 6 months (assessed on a 5-point Likert scale) better with ketorolac injection than that provided with steroid injection for symptomatic knee osteoarthritis? Methods: In this randomized controlled double-blinded study, intra-articular injections will be given for symptomatic knee osteoarthritis patients. 30 patients each will be enrolled in the two groups – steroid and ketorolac. Patients will be followed-up at 2 weeks, 6 weeks, 3 months and 6 months to assess pain relief using VAS, functional outcome using WOMAC score, KOOS score and SF-36 score, as well as patient satisfaction on a 5-point Likert scale. Expected Outcomes: We hypothesize that ketorolac will provide better pain relief, functional outcome and patient satisfaction in knee osteoarthritis patients, at the given time-points. If it is proven, it can also be readily used as a cost-effective management option for symptomatic knee osteoarthritis patients. |