Investigating the Effect of Genicular Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis in patients refferd to Urmia Imam Khomeini Hospital
Determining the effect of genicular artery embolization in the treatment of pain secondary to knee arthritis
Design
This will be a single-center, unblinded, single-group clinical trial that will evaluate the reduction of knee pain symptoms in patients with knee osteoarthritis after geniculate artery embolization compared to the contralateral knee.
Settings and conduct
This clinical trial will be conducted on 23 patients with osteoarthritis in both knees at Imam Khomeini Hospital in Urmia. The study will be open-label, and the patients will be informed about the intervention and the specific knee being treated.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Age between 45 and 75 years with symptoms of knee pain in both knees.
2. Radiographic findings in both knees with a grade of 2 to 4 based on the Kellgren-Lawrence classification
3. VAS score above 50/100 for both knees.
4. Pain resistant to medical and supportive treatments for a duration of 3 months.
5. 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.
Exclusion Criteria:
1. Pregnancy.
2. GFR < 60 ml/min/1.73m².
3. Sensitivity to contrast agents.
4. BMI > 40 kg/m².
5. History of joint injection in the last 3 months.
6. Joint infection or inflammatory joint disease.
7. Life expectancy of less than 2.5 years.
8. Platelet count less than 30,000 per microliter.
9. Allergy to iodinated contrast agents.
10. Presence of joint prosthesis or history of joint surgery.
11. Kellgren-Lawrence grade 4 findings.
12. Absence of palpable pulse.
Intervention groups
Patients are subjected to embolization of the geniculate artery of one knee and the condition of the intervened knee is compared with the opposite knee.
Main outcome variables
Pain score; functional performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240615062136N1
Registration date:2024-10-18, 1403/07/27
Registration timing:registered_while_recruiting
Last update:2024-10-18, 1403/07/27
Update count:0
Registration date
2024-10-18, 1403/07/27
Registrant information
Name
Arian Haghtalab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 7286
Email address
haghtalab.a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Genicular Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis in patients refferd to Urmia Imam Khomeini Hospital
Public title
Investigating the Effect of Genicular Artery Embolization for the Treatment of Knee Osteoarthritis Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
2
Patient's Knee
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences
Before, after one month and three months of the intervention
Method of measurement
Visual Analogue Scale
2
Description
Functional Performance
Timepoint
Before, after one month and three months of the intervention
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index
Secondary outcomes
empty
Intervention groups
1
Description
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.