Osteoarthitis
Conditions
Keywords
osteoarthritis, genicular artery embolization, pain
Brief summary
The goal of this randomized clinical trial is to evaluate the role of genicular artery embolization (GAE) in treating persistent pain in patients with severe knee osteoarthritis who have failed conservative treatment and may be unable to undergo surgical treatment because of significant medical commodities. The main questions it aims to answer are: Does genicular artery embolization reduce persistent knee pain in patients with severe knee osteoarthritis? Researchers will compare patients who undergo genicular artery embolization with patients who continue conservative treatment, including NSAIDs, physiotherapy, weight reduction programs, and intra-articular injections, to evaluate differences in pain. Participants will: * Undergo assessment of knee pain and function using the Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score before treatment. * Be randomly assigned to either genicular artery embolization or continued conservative treatment. * Have pain and functional outcomes assessed before treatment and at 6 weeks, 3 months, and 6 months after the intervention.
Detailed description
Randomized control trial were subjects will be chosen through envelop opaque technique, and all subjects will be included according to inclusion and exclusion criteria The intervention of interest is genicular artery embolization and our main outome is assessing pain post procedure The control group will be patients on conservative therapy such as (NSAIDS, physiotherapy, weight reduction programm, Intrarticular injections) This control group will be compared to the other two limbs of the study which are patinet who undergo embolization Assessing pain as primary objective and function as secondary objective will be through used tools such as WOMAC score, VAS, score. Pain and funtion variables will be collected in the following manner: * Pre procedure * Six weeks after the procedure - 3 months after the procedure - 6 months after the procedure The data will be entered to Microsoft Excel and then be analyzed on Statistical Package for the Social Sciences (SPSS) version 22.
Interventions
PROCEDUREembolization therapy
GAE: Genicular artery embolization GAE To be performed under local anesthesia \- Immediately prior to the procedure, the focal areas of pain identified by the patient should be marked with a radiopaque marker.. Access to the ipsilateral common femoral artery is performed with a 21-gauge needle, with exchange to a 3-French vascular sheath which is replaced by 5 French one 11 cm length by using a metallic guide wire. * 4Fr. 65-cm-angled Glidecath to be advanced into the mid-to-distal portion of the superficial femoral artery, proximal to the descending genicular artery origin. * The selection of which artery to embolize is based on the angiographic evidence of hyperemia at the cartilage level Embolization is performed with 100-300mm Embozene particles. Embolization is performed until distal hypervascularity resolved, yet normal arterial flows is preserved within the selected artery. * After embolization, a completion femoral artery angiogram should be performed. Compression for 5 minute
OTHERConservative treatment
NSAIDS, physiotherapy, weight reduction programm, or Intrarticular injections for at least 3-6 months
Sponsors
King Abdullah International Medical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized control trial were subjects will be chosen through envelop opaque technique, and all subjects will be included according to inclusion and exclusion criteria The intervention of interest is genicular artery embolization and our main outome is assessing pain post procedure The control group will be patients on conservative therapy such as (NSAIDS, physiotherapy, weight reduction programm, Intrarticular injections) This control group will be compared to the other two limbs of the study which are patinet who undergo embolization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older of either sex. Diagnosis of knee osteoarthritis with a Kellgren-Lawrence grade of 3 or higher. Persistent knee pain resistant to conservative treatment for at least 3 months. Conservative treatment includes NSAIDs, physiotherapy, weight reduction programs, and intra-articular injections. Patients with multiple comorbidities who are indicated for operative treatment, such as total knee arthroplasty, for pain management but are unable to undergo surgery due to their medical status.
Exclusion criteria
Previous knee arthroplasty in the affected knee. Known malignancy. Local infection. Rheumatoid arthritis. Intra-articular injection in the affected knee within the previous 6 months. Body weight greater than 150 kg. Renal impairment. Irreversible coagulopathy. Peripheral vascular disease. Study Population: Patients will be recruited from King Abdulaziz Medical City, National Guard Hospital, Jeddah, Saudi Arabia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain evaluation post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index | from enrollment until 6 months after the procedure is done | To evaluate the role of genicular artery embolization in treatment of persistent pain using Western Ontario and McMaster Universities Osteoarthritis Index in patients with severe knee osteoarthritis. For the Western Ontario and McMaster Universities Osteoarthritis Index score it includes 3 parameters which are pain, stiffness, and physical function and scored from 0 to 4 having 0 as None and 4 as the most extreme for each variable, and for the total score having 0 is the best response and 96 is the worst. |
| Pain evaluation post Genicular artery embolization using Visual Analogue Scale | from enrollment until 6 months after the procedure is done | To evaluate the role of genicular artery embolization in treatment of persistent pain using Visual Analogue Scale in patients with severe knee osteoarthritis. For Visual Analogue Scale score it is used to assess the pain only from 0 to 10 having 0 is None and 10 is the most Extreme |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional status post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index | from enrollment until 6 months after the procedure is done | To evaluate the functional status post genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index in patients with severe knee osteoarthritis. For the Western Ontario and McMaster Universities Osteoarthritis Index score it can be used for functional status evaluation also because it includes 3 parameters which are pain, stiffness, and physical function and scored from 0 to 4 having 0 as None and 4 as the most extreme for each variable, and for the total score having 0 is the best response and 96 is the worst. |
Countries
Saudi Arabia
Contacts
CONTACTMajd A. Saemaldahar, Bacheloar
CONTACTOmar A. Batouk, PHD
STUDY_DIRECTORMajd A. Saemaldahar, Bacheloar
King Abdullah International Medical Research Center
PRINCIPAL_INVESTIGATOROmar A. Batouk, PHD
King Abdullah International Medical Research Center
Outcome results
None listed