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CTRI Number  CTRI/2022/09/045508 [Registered on: 14/09/2022] Trial Registered Prospectively
Last Modified On: 09/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of genicular artery embolization, in which the blood vessels supplying the diseased knee are blocked using a minimally invasive angiography-based technique, and compare it with standard therapy, in the patients suffering from osteoarthritis of the knee 
Scientific Title of Study   Genicular artery embolization for the management of osteoarthritis of the knee: A prospective randomized study  
Trial Acronym  GAEMOK 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subhash Kumar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Radiodiagnosis, Ground Floor, IPD-D Block, Next to DSA room, Phulwarisharif

Patna
BIHAR
801507
India 
Phone  8676836533  
Fax    
Email  drsubhash.dm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subhash Kumar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Radiodiagnosis, Ground Floor, IPD-D Block, Next to DSA room, Phulwarisharif

Patna
BIHAR
801507
India 
Phone  8676836533  
Fax    
Email  drsubhash.dm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subhash Kumar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Radiodiagnosis, Ground Floor, IPD-D Block, Next to DSA room, Phulwarisharif

Patna
BIHAR
801507
India 
Phone  8676836533  
Fax    
Email  drsubhash.dm@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna 
Address  All India Institute of Medical Sciences Patna, Phulwarisharif, Patna, Bihar, India-801507 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
All India Institute of Medical Sciences Patna  Phulwarisharif, Patna, Bihar, India-801507 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Subhash Kumar  All India Institute of Medical Sciences Patna  Department of Radiodiagnosis, IPD D Block, Phulwarisharif, Patna, Bihar, India - 801507
Patna
BIHAR 
8676836533

drsubhash.dm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Genicular artery embolization  After femoral artery puncture and insertion of a vascular sheath, the diseased knee shall undergo DSA which will provide anatomic vascular roadmap for infusion of the embolizing material. The neo-angiogenesis will be seen at areas of blush and supplied by the genicular arteries. Then after super-selective catheterization with a microcatheter, embolization material (polyvinyl alcohol particles) will be injected via the feeder arteries. The usual size is 100 microns (45–150 microns range). Procedure shall be performed on single sitting, whether it is single knee or both knees, via a femoral puncture, under local anesthesia/monitored anesthesia/sedation as applicable. After the procedure, monitoring shall be done for 6 hours and discharged same day to home.  
Comparator Agent  Standard therapy  Shall consist of physiotherapy and medical management 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Radiographically proven knee osteoarthritis in either sex of age more than 18 years with any radiological grade
Patients not responding to conservative management after 6 weeks of initial diagnosis of osteoarthritis on radiographs
Patients deemed unfit for surgery or unwilling for surgery for knee osteoarthritis 
 
ExclusionCriteria 
Details  Poor general condition precluding digital subtraction angiography and embolization under local anesthesia for approximately 2 hours duration
Prior surgery in the knee joint
Intra-articular injections (steroid, platelet rich plasma or hyaluronic acid, or any such therapy) within 6 weeks of the enrollment in the trial
Current or prior infection or trauma to the knee
Life expectancy less than 6 months
Known advanced atherosclerosis (plaque that builds within the vessels that lead blood to the heart)
Rheumatoid or infectious arthritis
Iodine allergy
Kidney disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in VAS and KOOS scores  1 day, 7 days, 30 days, 90 days and 120 days 
 
Secondary Outcome  
Outcome  TimePoints 
Technical success in performing the genicular artery embolization  Immediate 
Complications such Allergy, Anaphylaxis, Renal failure, hematoma, gangrene, arteriovenous fistula, skin erythema (most common), skin necrosis and ulceration, joint pain, bone necrosis, nausea and vomiting, focal neurological deficits  1 day, 7 days, 30 days, 90 days and 120 days 
Change in WORMS score on MRI  6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/09/2022 
Date of Study Completion (India) 24/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background: Treatment options for osteoarthritis of the knee include non-pharmacologic and pharmacologic therapies and knee joint replacement surgery, depending on the severity and degree of pain. However, a large number of patients are resistant to conventional nonsurgical therapies or are ineligible / unwilling for surgery. As OA is known to cause neo-angiogenesis, which adds to the pain and the slow progressive joint damage, it offers a potential target of therapy by endovascular embolization of the genicular arteries by devascularizing the hypertrophied and hypervascular synovium of the involved knee.

Novelty: Genicular artery embolization (GAE) is a newly described technique, and no randomized controlled studies exist till date from India to prove its efficacy.

Objectives: To evaluate improvement in pain and functional outcomes, measured by the Visual Analog Scale (VAS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) in knee osteoarthritis after GAE

Methods: Knee OA patients reporting to the orthopaedics outpatient clinic and not responding to conventional management for 6 weeks, will be enrolled in the study and randomized in two arms, the control arm shall undergo further standard conventional management and the interventional arm shall undergo a single session of GAE under local anesthesia as a daycare procedure, along with standard care. The baseline scores of VAS and KOOS will be compared with those at one day, one week, one month, three months and six months of the intervention.

Expected outcome: GAE will provide superior outcomes of both pain control and functional outcomes, measured by the VAS and KOOS, as compared to conventional management.

 
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