An interventional study of Embolization and Sham embolization in Osteoarthritis, Knee, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
In this double blind randomized sham controlled study the investigators want to establish the efficacy of transcatheter arterial embolization of neovessels for patients with symptomatic mild to moderate knee osteoarthritis after 4 months compared to a sham-embolization.
Rationale:
Transcatheter arterial embolization has recently been proposed as an efficacious therapy for therapy-resistant osteoarthritis of the knee, providing substantial pain reduction at short-term as well as long-term follow-up up till 4 years.
A potential working mechanism of treatment effect is that the normalization of the amount of blood vessels and blood flow achieved by embolization reduces inflammation, resulting in pain reduction
Objective:
The main objective is to assess whether transcatheter arterial embolization of neovessels in patients with symptomatic knee OA results in significant pain reduction after 4 months compared to sham treatment.
The investigators hypothesize that novel transcatheter arterial embolization of neovessels is a feasible, effective, and safe treatment for patients with symptomatic radiographic knee OA, resulting in significant improvement of pain symptoms in a period of 4 months follow-up compared to sham embolization.
Secondary objectives are
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 58 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exlusion criteria:
Group undergoes transcatheter arterial embolization of neovessels around the knee.
Procedure: Embolization
Group undergoes sham embolization
Procedure: Sham embolization
transcatheter arterial embolization of neovessels around the knee
Sham transcatheter arterial embolization of neovessels in the knee
KOOS pain sub score
KOOS pain sub score after 4 months
Time frame: 4 months
Total KOOS
Total KOOS result
Time frame: 1,4,8,12 month(s)
painDETECT questionnaire
painDETECT questionnaire results
Time frame: 1,4,8,12 month(s)
ICOAP questionnaire
ICOAP questionnaire results
Time frame: 1,4,8,12 month(s)
Pain Score 0-10 Numerical Rating Scale (NRS)
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time frame: 1,4,8,12 month(s)
EQ-5D-5L questionnaire
EQ-5D-5L questionnaire results
Time frame: 1,4,8,12 month(s)
Pressure pain threshold testing
Pressure pain threshold testing results
Time frame: 1,4,8,12 month(s)
Knee MRI
Knee MRI scan results
Time frame: 1 and 4 month(s)
Plan to share: Yes — We are willing the share all our available unidentified data on reasonable request
Supporting information: Study protocol
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center