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CTRI Number  CTRI/2024/01/061459 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 10/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   PRP vs HA in osteoarthritis knee: which one is better for your knee ? 
Scientific Title of Study   Comparison Of Ultrasound Guided Intraarticular Injection Of Platelet Rich Plasma Versus Hyaluronic Acid In Improving Cartilage Thickness And Physical Functions In Patients With Primary Osteoarthritis Of Knee: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumit Debnath 
Designation  Post graduate Trainee 
Affiliation  Regional Institute Of Medical Sciences, Imphal, Manipur 
Address  Department of Physical Medicine and Rehabilitation, RIMS, Imphal

Imphal West
MANIPUR
795004
India 
Phone  6033234396  
Fax    
Email  sumit.dnath1989@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nongmaithem Romi Singh 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences , Imphal
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences , Imphal
Imphal West
MANIPUR
795004
India 
Phone  9436025822  
Fax    
Email  dr.romi.singh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sumit Debnath 
Designation  Post graduate Trainee 
Affiliation  Regional Institute Of Medical Sciences, Imphal, Manipur 
Address  Department of Physical Medicine and Rehabilitation, RIMS, Imphal

Imphal West
MANIPUR
795004
India 
Phone  6033234396  
Fax    
Email  sumit.dnath1989@gmail.com  
 
Source of Monetary or Material Support  
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal 
 
Primary Sponsor  
Name  No Primary Sponsor 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 
DrSumit Debnath  Regional Institute of Medical Sciences , Imphal  Physical Medicine and Rehabilitation Department
Imphal West
MANIPUR 		 6033234396

sumit.dnath1989@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board RIMS  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 
Comparator Agent  Hyaluronic Acid  6ml of high molecular weight hyaluronic acid will be given once intraarticularly to the affected knee under ultrasound guidance 
Intervention  Platelet rich plasma   4ml of Platelet rich plasma will be given once intraarticularly to the affected knee under ultrasound guidance 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age group 40 to 65 years
2. Patients with primary knee osteoarthritis fulfilling 2016 ACR(American college of Rheumatology) revised criteria for early diagnosis of knee osteoarthritis(clinical and radiographic)
3. Osteoarthritis of knee with Kellgren-Lawrence grade upto 3
4. Willingness to participate in the study and comply with treatment and follow up
5.VAS>4 
 
ExclusionCriteria 
Details  1. Recent knee trauma or knee surgery
2. Knee deformity or knee infection
3. Metabolic disease of bone
4. Cognitive impairment
5. Uncontrolled diabetes mellitus
6. Thrombocytopenia(Platelet count<150000/mcl
7. Intraarticular steroid injection during past 3 months
8. BMI>30 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Knee cartilage thickness assessment by MSK ultrasound  Baseline, 3 month, 6 month and 9 month 
 
Secondary Outcome  
Outcome  TimePoints 
VAS score, WOMAC score  Baseline, 3 month, 6 month & 9 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   20/02/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sumit.dnath1989@gmail.com].

  6. For how long will this data be available start date provided 03-01-2025 and end date provided 03-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Osteoarthritis of knee is a chronic disease with loss of joint surface cartilage. Pain, stiffness and joint deformity affecting ones day to day activities. The aim of the study is to compare ultrasound guided intra articular injection of platelet rich plasma versus hyaluronic acid in improving cartilage thickness and physical functions in patients with primary osteoarthritis of knee. Outcomes will be measured at the end of 12 weeks, 24 weeks and 36 weeks. Data will be analysed using SPSS 21 version. Chi-square test, student t test and ANOVA will be used and p value<0.05 will be taken as significant. 
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