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IRCT20240615062136N1 IRCT 2024-10-18 Oroumia University of Medical Sciences Investigating the Effect of Genicular Artery Embolization for the Treatment of Knee Osteoarthritis Pain Investigating the Effect of Genicular Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis in patients refferd to Urmia Imam Khomeini Hospital 2024-09-05 anticipated 23 Complete https://irct.ir/trial/78238 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 3 Osteoarthritis of Knee. Intervention group: Patients who undergo embolization of the genicular artery of one knee. Both knees of each patient are examined, and the knees are randomly assigned to either intervention or control (23 intervention knees and 23 control knees). A 2.8-F microcatheter is selectively used to target the genicular arteries in the knee area with the most severe pain. Digital subtraction angiography (DSA) is performed at a low frame rate (1-2 frames per second) and continues until "tumor blush" is observed in delayed images. Embolization is then performed using 150-250 micron embolic particles. The embolization technique involves mixing the particles in a solution with 10 ml of contrast medium. After mixing the liquid to create a homogeneous solution, 2 ml is injected. The injection is performed with repeated digital subtraction angiography until tumor blush is no longer observed in delayed images. This process is repeated for each genicular artery feeding the knee area with the most severe pain. A repeat angiography via the femoral artery is performed to eliminate any untreated branches. All individuals receive an antibiotic dose before the procedure and for 5 days afterward. Pain medication is prescribed for the post-embolization period (up to 1 week after the procedure) in all groups. Patients are discharged 6 hours after the procedure. An initial follow-up phone call is made the day after the procedure to assess acute events. Subsequent follow-ups are conducted one month after the procedure. All post-operative data is collected and recorded by study staff.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Dependent on the approval of the hospital's ethics committee
public Parisa Noorabadi
Imam Khomeini Hospital, Ershad St., Modarres Blvd.
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3345 7286 noorabadi.par@umsu.ac.ir Oroumia University of Medical Sciences scientific Parisa Noorabadi
Imam Khomeini Hospital, Ershad St., Modarres Blvd.
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3345 7286 noorabadi.par@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Age between 45 and 75 years with symptoms of knee pain in both knees Radiographic findings in both knees with a grade of 2 to 4 based on the Kellgren-Lawrence classification VAS score above 50/100 for both knees Pain resistant to medical and supportive treatments for a duration of 3 months All patients must agree not to use any oral or injectable painkillers and supplements during the study period and, if necessary, take medications according to the study protocol 45 years 75 years Both Pregnancy GFR < 60 ml/min/1.73m² Sensitivity to contrast agents BMI > 40 kg/m² History of joint injection in the last 3 months Joint infection or inflammatory joint disease Life expectancy of less than 2.5 years Platelet count less than 30,000 per microliter Allergy to iodinated contrast agents Presence of joint prosthesis or history of joint surgery Absence of palpable pulse M17 Osteoarthritis of knee Treatment - Surgery Intervention group: Patients who undergo embolization of the genicular artery of one knee. Both knees of each patient are examined, and the knees are randomly assigned to either intervention or control (23 intervention knees and 23 control knees). A 2.8-F microcatheter is selectively used to target the genicular arteries in the knee area with the most severe pain. Digital subtraction angiography (DSA) is performed at a low frame rate (1-2 frames per second) and continues until "tumor blush" is observed in delayed images. Embolization is then performed using 150-250 micron embolic particles. The embolization technique involves mixing the particles in a solution with 10 ml of contrast medium. After mixing the liquid to create a homogeneous solution, 2 ml is injected. The injection is performed with repeated digital subtraction angiography until tumor blush is no longer observed in delayed images. This process is repeated for each genicular artery feeding the knee area with the most severe pain. A repeat angiography via the femoral artery is performed to eliminate any untreated branches. All individuals receive an antibiotic dose before the procedure and for 5 days afterward. Pain medication is prescribed for the post-embolization period (up to 1 week after the procedure) in all groups. Patients are discharged 6 hours after the procedure. An initial follow-up phone call is made the day after the procedure to assess acute events. Subsequent follow-ups are conducted one month after the procedure. All post-operative data is collected and recorded by study staff. Pain Score. Timepoint: Before, after one month and three months of the intervention. Method of measurement: Visual Analogue Scale. Functional Performance. Timepoint: Before, after one month and three months of the intervention. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis Index. Oroumia University of Medical Sciences Approved 2024-07-10 Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences Imam Khomeini Hospital, Ershad St., Modarres Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)