Neovascularization Embolisation for Knee Osteoarthritis.(NEO)

Osteoarthritis, Knee Clinical Trial

— NEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884049
• Other study ID #: METC 2018-081
• Secondary ID: 2018-081
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 30, 2023
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Embolization
transcatheter arterial embolization of neovessels around the knee
• Sham embolization
Sham transcatheter arterial embolization of neovessels in the knee

Locations

Country	Name	City	State
Netherlands	ErasmusMC	Rotterdam	Zuid Holland

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Stichting Coolsingel, William Cook Europe

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS pain sub score	KOOS pain sub score after 4 months	4 months
Secondary	Total KOOS	Total KOOS result	1,4,8,12 month(s)
Secondary	painDETECT questionnaire	painDETECT questionnaire results	1,4,8,12 month(s)
Secondary	ICOAP questionnaire	ICOAP questionnaire results	1,4,8,12 month(s)
Secondary	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)
Secondary	EQ-5D-5L questionnaire	EQ-5D-5L questionnaire results	1,4,8,12 month(s)
Secondary	Pressure pain threshold testing	Pressure pain threshold testing results	1,4,8,12 month(s)
Secondary	Knee MRI	Knee MRI scan results	1 and 4 month(s)