Neovascularization Embolisation for Knee Osteoarthritis.(NEO) (NEO)

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Embolization; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015CE
      • ErasmusMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embolization group; Group undergoes transcatheter arterial embolization of neovessels around the knee.	Procedure: Embolization; transcatheter arterial embolization of neovessels around the knee
Sham Comparator: Sham Embolization Group; Group undergoes sham embolization	Procedure: Sham embolization; Sham transcatheter arterial embolization of neovessels in the knee

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; embolization; arterial; ranscatheter
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: METC 2018-081; 2018-081 (Registry Identifier: METC ErasmusMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are willing the share all our available unidentified data on reasonable request
• IPD Sharing Time Frame: is available upon request as of now and will be available for the next 15 years.
• IPD Sharing Access Criteria: after written request to PI; after signing Data Transfer Agreement; No commercial use for data allowed by requesting party.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No