None listed
Conditions
Brief summary
Genicular artery embolisation (GAE) is a procedure involving injection of small particles into knee joint arteries. This inhibits growth of new blood vessels (neovascularity) and decreases inflammation, thereby reducing knee pain and disability. We proprose GAE offers an effective and minimally invasive alternative to treat knee pain in patients with TKR. Up to 20% of TKR patients are dissatisfied with pain control; GAE can provide a nonsurgical alternative to manage pain. We aim to perform a prospective, double-blinded, randomised control trial to assess the safety and efficacy of GAE compared with sham procedure in the treatment of knee pain in patients with TKRs.
Interventions
Genicular artery embolisation (GAE) is a procedure involving injection of small particles into knee joint arteries. It involves digital subtraction angiography to confirm areas of enhancement ("tumour blush") followed by embolisation of arteries using particles called embospheres. This inhibits growth of new blood vessels (neovascularity) and decreases inflammation.
Trans-Arterial Embolisation of the Genicular Arteries (GAE) procedure:
1. Pre-procedural Consent: Highlighting complications of th
Genicular artery embolisation (GAE) is a procedure involving injection of small particles into knee joint arteries. It involves digital subtraction angiography to confirm areas of enhancement ("tumour blush") followed by embolisation of arteries using particles called embospheres. This inhibits growth of new blood vessels (neovascularity) and decreases inflammation. Trans-Arterial Embolisation of the Genicular Arteries (GAE) procedure: 1. Pre-procedural Consent: Highlighting complications of the procedure. 2. Trans-femoral arterial access. 3. Allergies: Medication or iodinated contrast. 4. Light sedation (intravenous) - Midazolam and Fentanyl as needed. 5. Angiography and intervention: a. Selective catheter angiography of superficial femoral artery identifying geniculate vessels perfusing areas of synovial hyperaemia “blushing”. b. Super selective micro-catheterisation and embolisation of the target vessels “blush areas” with a mixture of iodinated contrast media and 100-300µm Embosphere particles (Merit Medical, USA). c. Technical success is defined as an absent “blush” of feeding arteries. d. Final angiography is performed to assess for complications of non-target distal embolisation. 6. Puncture site closure: FemoSeal® vascular closure device. - This procedure will be a one-off 30 minute procedure performed by an interventional radiologist - This procedure will be carried out on patients at least 12 months following total knee replacement, and at least 6 months of insufficient response to conservative and medical therapy - Patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months and 12 months - As this is a one-off procedure there will be no need to monitor adherence to the intervention
Sponsors
Dr Julian Soares
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patient willing and able to consent to participate in the study Age 40-75 years Knee pain for a duration of > 6 months Insufficient response to conservative and medical treatment for > 6 months Be able to lie flat for 90 minutes Baseline VAS (visual analogue scale, 0–100) > 50
Exclusion criteria
Musculoskeletal comorbidity (e.g., rheumatoid arthritis, gout) Contraindications for angiography Infectious arthritis Renal impairment (estimated glomerular filtration rate <30) Uncorrectable coagulopathy Requires oxygen on ambulation Life expectancy <1 year Communication difficulty due to language barriers History of peripheral arterial disease with intermittent claudication and/or rest pain Pregnancy or positive pregnancy test Trauma to the knee within last 12 months Correctable causes for painful total knee replacement (Infection, malalignment, loosening) identified by treating surgeon
Outcome results
None listed