The aim of this study is to investigate the safety and efficacy of geniculate artery embolization (GAE) as pain treatment in patients with mild to moderate knee osteoarthritis.
This is a single arm, prospective, pilot study investigating the safety and efficacy of GAE as pain treatment in patients with mild to moderate knee osteoarthritis. Patient related outcome measurements (PROMs), physical tests and several image modalities will be conducted. It may form the grounding for further research in the shape of a larger randomized clinical trial. The hypothesis is, that GAE will reduce synovitis and thereby pain in the patient group. This may secondary improve physical function and reduce consumption of analgesics.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
The procedure will be performed in local anaesthesia. An antegrade percutaneous transfemoral approach with super-selective catheterisation of geniculate neovesselswill be performed and subsequently the target will be pruned with microspherical embolic material.
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Changes in Visual Analog Scale (VAS) as a measure of efficacy
Reported as worst pain experienced during walking in the last 24 hours on a 100 mm scale from "No pain" to "Pain as bad as it could possibly be".
Time frame: 6 months post GAE
Dexa scan
Changes in bone mineral density
Time frame: Baseline vs 6 months post GAE
Changes in Visual Analog Scale (VAS) as a measure of efficacy
Reported as worst pain experienced during walking in the last 24 hours on a 100 mm scale from "No pain" to "Pain as bad as it could possibly be".
Time frame: 1 week, 1, 2, 3, 4, and 5 months post GAE
Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)
KOOS assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Time frame: Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE.
Changes in IPAQ (international physical activity questionnaire)
Questionnaire on daily physical activity
Time frame: Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE
Changes in use of analgesics
(paracetamol, NSAID, opioid, or neuropathic agent)
Time frame: Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE
Changes in 30 seconds Chair Stand Test
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The maximum number of chair stand repetitions in a 30 second period.
Time frame: Baseline vs. 1 and 6 months post GAE.
Changes in Stair Climb Test
The time (in seconds) it takes to ascend and descend a flight of stairs.
Time frame: Baseline vs. 1 and 6 months post GAE.
Changes in 40 meters Fast Paced Walk Test
A fast-paced walking test that is timed over 4\*10 meters for a total of 40 meters.
Time frame: Baseline vs. 1 and 6 months post GAE.
Subjective response to the treatment on a five point Likert scale
(none=no good at all, ineffective treatment; poor=some effect but unsatisfactory; fair=reasonable effect but could be better; good=satisfactory effect with occasional episodes of pain or stiffness; excellent=ideal response, virtually pain free)
Time frame: 6 months post GAE
MRI
Changes in synovial thickness (CE-MRI), effusion (Non CE-MRI) and synovial perfusion (DCE-MRI).
Time frame: Baseline vs. 1 and 6 months post GAE
Ultrasound
Changes in synovial thickness, effusion and perfusion (doppler).
Time frame: Baseline vs. 1 and 6 months post GAE