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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  
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 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  
Status 
Not Applicable 
 
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. 
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