NCT03884049

Neovascularization Embolisation for Knee Osteoarthritis.(NEO)

Novel Transcatheter Arterial Embolization for Treatment of Knee Osteoarthritis: a Randomized Sham-controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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 1. to assess whether reduction of neovessels is related to pain relief, 2. to explore whether decrease of inflammation is a mediating factor between neovessel reduction and pain relief, 3. to assess whether transcatheter arterial embolization reduction of neovessels decreases peripheral and central pain sensitization and 4. 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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
PROCEDURE	Embolization	transcatheter arterial embolization of neovessels around the knee
PROCEDURE	Sham embolization	Sham transcatheter arterial embolization of neovessels in the knee

Timeline

• Start date: 2019-06-05
• Primary completion: 2022-05-05
• Completion: 2023-01-30
• First posted: 2019-03-21
• Last updated: 2024-04-01

Locations

1 site across 1 country: Netherlands