Neovascularization Embolisation for Knee Osteoarthritis.(NEO)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteoarthritis (Knee)
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Double-blinded randomized placebo-controlled clinical trialMasking: Double (Participant, Investigator)Masking Description: Double blindedPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 i...
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 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.
Tracking Information
- NCT #
- NCT03884049
- Collaborators
- William Cook Europe
- Stichting Coolsingel
- Investigators
- Principal Investigator: Edwin Edwin, MD, PhD Erasmus Medical Center Principal Investigator: Adriaan Moelker, MD, PhD Erasmus Medical Center