Clinical trial NCT03884049: Neovascularization Embolisation for Knee Osteoarthritis.(NEO)
Official title: Novel Transcatheter Arterial Embolization for Treatment of Knee Osteoarthritis: a Randomized Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: ranscatheter
embolization
osteoarthritis
arterial
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: William Cook Europe
name: Stichting Coolsingel
First posted: 2019-03-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized placebo-controlled clinical trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: KOOS pain sub score
timeFrame: 4 months
Secondary outcomes:
measure: Total KOOS
timeFrame: 1,4,8,12 month(s)
measure: painDETECT questionnaire
timeFrame: 1,4,8,12 month(s)
measure: ICOAP questionnaire
timeFrame: 1,4,8,12 month(s)
measure: Pain Score 0-10 Numerical Rating Scale (NRS)
timeFrame: 1,4,8,12 month(s)
measure: EQ-5D-5L questionnaire
timeFrame: 1,4,8,12 month(s)
measure: Pressure pain threshold testing
timeFrame: 1,4,8,12 month(s)
measure: Knee MRI
timeFrame: 1 and 4 month(s)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: ErasmusMC
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Edwin Edwin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Adriaan Moelker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Zadelhoff TA, Moelker A, Bierma-Zeinstra SMA, Bos PK, Krestin GP, Oei EHG. Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial. Trials. 2022 Jan 8;23(1):24. doi: 10.1186/s13063-021-05942-x.