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

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2022/09/045508

Lead Sponsor: All India Institute of Medical Sciences Patna

Brief Summary: Background: Treatment options for osteoarthritisof the knee include non-pharmacologic and pharmacologic therapies and kneejoint replacement surgery, depending on the severity and degree of pain.However, a large number of patients are resistant to conventional nonsurgicaltherapies or are ineligible / unwilling for surgery. As OA is known to causeneo-angiogenesis, which adds to the pain and the slow progressive joint damage,it offers a potential target of therapy by endovascular embolization of thegenicular arteries by devascularizing the hypertrophied and hypervascularsynovium of the involved knee.

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

Objectives: To evaluate improvement inpain and functional outcomes, measured by the Visual Analog Scale (VAS) and theKnee Injury and Osteoarthritis Outcome Score (KOOS) in knee osteoarthritisafter GAE

Methods: Knee OA patients reporting tothe orthopaedics outpatient clinic and not responding to conventionalmanagement for 6 weeks, will be enrolled in the study and randomized in twoarms, the control arm shall undergo further standard conventional managementand the interventional arm shall undergo a single session of GAE under localanesthesia as a daycare procedure, along with standard care. The baselinescores of VAS and KOOS will be compared with those at one day, one week, onemonth, three months and six months of the intervention.

Expected outcome: GAE will providesuperior outcomes of both pain control and functional outcomes, measured by theVAS and KOOS, as compared to conventional management.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in VAS and KOOS scores	1 day, 7 days, 30 days, 90 days and 120 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): All India Institute of Medical Sciences Patna
🇮🇳
Patna, BIHAR, India
All India Institute of Medical Sciences Patna
🇮🇳Patna, BIHAR, India
Subhash Kumar
Principal investigator
8676836533
drsubhash.dm@gmail.com