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CTRI Number  CTRI/2022/11/047701 [Registered on: 28/11/2022] Trial Registered Prospectively
Last Modified On: 18/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two different ultrasound techniques for cooled radiofrequency ablation treatment of knee osteoarthritis 
Scientific Title of Study   A Randomized Controlled Trial to compare the conventional and revised anatomical landmarks for ultrasound guided cooled radiofrequency ablation of genicular nerves in patients with chronic 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 Divya V 
Designation  Postgraduate student 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anaesthesia Lady Hardinge Medical College

New Delhi
DELHI
110001
India 
Phone  8838966863  
Fax    
Email  divyavelu777@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Hayaran 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anaesthesia Lady Hardinge Medical College

New Delhi
DELHI
110001
India 
Phone  9873903603  
Fax    
Email  nhayaran97@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nitin Hayaran 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anaesthesia Lady Hardinge Medical College

New Delhi
DELHI
110001
India 
Phone  9873903603  
Fax    
Email  nhayaran97@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Lady Hardinge Medical College 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Shaheed Bhagat Singh Marg New Delhi 
Type of Sponsor  Government medical college 
 
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 Divya V  Lady Hardinge Medical College  Department of Anaesthesia
New Delhi
DELHI 		 08838966863

divyavelu777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound guided conventional anatomical landmarks  conventional technique does not effectively block the genicular nerves and does not provide effective pain relief determined by Oxford knee score at 1, 4 and 12 weeks after the procedure 
Intervention  Ultrasound guided revised anatomical landmarks  Ultrasound guided revised landmarks for better and accurate ablation of genicular nerves that is more effective in relieving pain determined by Oxford knee score at 1, 4 and 12 weeks after the procedure 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with symptomatic knee osteoarthritis graded II,III&IV according to the Kellgren-Lawrence system  
 
ExclusionCriteria 
Details  1. Pain and functional limitations due to rheumatoid arthritis, gout and psoriatic arthritis.
2. Active infection of knee joint
3. Patients receiving any other invasive treatment for knee osteoarthritis


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in the median Oxford Knee Score  after 1, 4 and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Median Numerical Rating Scale (NRS)   after 1, 4 and 12 weeks 
Proportion of patients developing skin burns, hematoma and numbness  immediately and within 1 week 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/11/2022 
Date of Study Completion (India) 01/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/02/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [divyavelu777@gmail.com].

  6. For how long will this data be available start date provided 18-02-2024 and end date provided 01-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Knee osteoarthritis is one of the most common degenerative conditions in the elderly age group. The definitive treatment is knee replacement surgery, but most of the patients will not be fit for surgery. Minimally invasive procedures like radiofrequency ablation of genicular nerves around the knee joint is a successful alternative for surgery. Cooled Radiofrequency ablation is a new modality that effectively ablates the genicular nerves. Previously it was done under fluoroscopy guidance but ultrasound guidance has better advantages of being radiation free and accurate capturing of nerves. Previous landmarks that have been used for ultrasound guided ablation did not cover the entire nerves, thus providing less pain relief. Recently developed revised anatomical landmarks effectively block the genicular nerves and provide better pain relief than conventional technique. 
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