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
|
|
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. |