Neovascularization Embolisation for Knee Osteoarthritis.(NEO)

  • STATUS
    Recruiting
  • End date
    Nov 1, 2021
  • participants needed
    58
  • sponsor
    Erasmus Medical Center
Updated on 12 February 2021
conservative management
osteoarthritis
knee pain

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.

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.

Details
Condition Osteoarthritis of knee, Gonarthrosis, knee osteoarthritis
Treatment embolization, Sham embolization
Clinical Study IdentifierNCT03884049
SponsorErasmus Medical Center
Last Modified on12 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Osteoarthritis of knee?
Do you have any of these conditions: Gonarthrosis or Osteoarthritis of knee or knee osteoarthritis?
Do you have any of these conditions: knee osteoarthritis or Osteoarthritis of knee or Gonarthrosis?
Age.18 years
Knee pain for a duration of 6 months
Knee pain (numeric rating scale 4 - 8) on at least half of the days in the preceding month at time of inclusion
There is insufficient response of conservative treatment for at least 6 months
Radiographic knee osteoarthritis (radiographic Kellgren and Lawrence grade 1-3)
Exlusion criteria
Contra-indications for MRI (e.g. metallic foreign bodies, etc.)
Contra-indications for angiography
Renal insufficiency, checked with blood sample test (GFR < 30 ml/min/1, 73 m2)
Known allergy to contrast agents
Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene
Women who are pregnant or lactating
Intermittent claudication of affected limb
Intra articular injections in the ipsilateral knee less than 6 months ago
On the waiting list for joint replacement surgery
Amitriptyline usage
Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene
Insufficient command of the Dutch or English language
Legally incompetent adults
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