Neovascularization Embolisation for Knee Osteoarthritis.(NEO)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Embolization
* Procedure: Sham embolization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded randomized placebo-controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization group<br>Group undergoes transcatheter arterial embolization of neovessels around the knee. | Procedure: Embolization<br>* transcatheter arterial embolization of neovessels around the knee<br>|
| Sham Comparator: Sham Embolization Group<br>Group undergoes sham embolization | Procedure: Sham embolization<br>* Sham transcatheter arterial embolization of neovessels in the knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS pain sub score | KOOS pain sub score after 4 months | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total KOOS | Total KOOS result | 1,4,8,12 month(s) | 
| painDETECT questionnaire | painDETECT questionnaire results | 1,4,8,12 month(s) | 
| ICOAP questionnaire | ICOAP questionnaire results | 1,4,8,12 month(s) | 
| Pain Score 0-10 Numerical Rating Scale (NRS) | 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). | 1,4,8,12 month(s) | 
| EQ-5D-5L questionnaire | EQ-5D-5L questionnaire results | 1,4,8,12 month(s) | 
| Pressure pain threshold testing | Pressure pain threshold testing results | 1,4,8,12 month(s) | 
| Knee MRI | Knee MRI scan results | 1 and 4 month(s) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ranscatheter, embolization, osteoarthritis, arterial