Neovascularization Embolisation for Knee Osteoarthritis.(NEO) (NEO)
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|ClinicalTrials.gov Identifier: NCT03884049|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: Embolization Procedure: Sham embolization||Not Applicable|
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
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
- to assess whether reduction of neovessels is related to pain relief,
- to explore whether decrease of inflammation is a mediating factor between neovessel reduction and pain relief,
- to assess whether transcatheter arterial embolization reduction of neovessels decreases peripheral and central pain sensitization and
- to assess whether transcatheter arterial embolization improve the outcome at 1, 4, 8 and 12 months compared to placebo of the: ICOAP, painDETECT, EQ-5D-5L questionnaires and NRS for pain.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blinded randomized placebo-controlled clinical trial|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double blinded|
|Official Title:||Novel Transcatheter Arterial Embolization for Treatment of Knee Osteoarthritis: a Randomized Sham-controlled Clinical Trial|
|Actual Study Start Date :||June 5, 2019|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
Experimental: Embolization group
Group undergoes transcatheter arterial embolization of neovessels around the knee.
transcatheter arterial embolization of neovessels around the knee
Sham Comparator: Sham Embolization Group
Group undergoes sham embolization
Procedure: Sham embolization
Sham transcatheter arterial embolization of neovessels in the knee
- KOOS pain sub score [ Time Frame: 4 months ]KOOS pain sub score after 4 months
- Total KOOS [ Time Frame: 1,4,8,12 month(s) ]Total KOOS result
- painDETECT questionnaire [ Time Frame: 1,4,8,12 month(s) ]painDETECT questionnaire results
- ICOAP questionnaire [ Time Frame: 1,4,8,12 month(s) ]ICOAP questionnaire results
- Pain Score 0-10 Numerical Rating Scale (NRS) [ Time Frame: 1,4,8,12 month(s) ]
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").
- EQ-5D-5L questionnaire [ Time Frame: 1,4,8,12 month(s) ]EQ-5D-5L questionnaire results
- Pressure pain threshold testing [ Time Frame: 1,4,8,12 month(s) ]Pressure pain threshold testing results
- Knee MRI [ Time Frame: 1 and 4 month(s) ]Knee MRI scan results
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884049
|Contact: Edwin Oei, MD, PhD||31 10 firstname.lastname@example.org|
|Contact: Tijmen A Zadelhof, PhD student||31 10 email@example.com|
|Rotterdam, Zuid Holland, Netherlands, 3015CE|
|Principal Investigator:||Edwin Edwin, MD, PhD||Erasmus Medical Center|
|Principal Investigator:||Adriaan Moelker, MD, PhD||Erasmus Medical Center|