Neovascularization Embolisation for Knee Osteoarthritis.(NEO) (NEO)
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ClinicalTrials.gov Identifier: NCT03884049 |
Recruitment Status :
Recruiting
First Posted : March 21, 2019
Last Update Posted : July 30, 2019
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Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis, Knee | Procedure: Embolization Procedure: Sham embolization | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 58 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Double-blinded randomized placebo-controlled clinical trial |
Masking: | Double (Participant, Investigator) |
Masking Description: | Double blinded |
Primary Purpose: | Treatment |
Official Title: | Novel Transcatheter Arterial Embolization for Treatment of Knee Osteoarthritis: a Randomized Sham-controlled Clinical Trial |
Actual Study Start Date : | June 5, 2019 |
Estimated Primary Completion Date : | November 1, 2021 |
Estimated Study Completion Date : | November 1, 2021 |

Arm | Intervention/treatment |
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Experimental: Embolization group
Group undergoes transcatheter arterial embolization of neovessels around the knee.
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Procedure: Embolization
transcatheter arterial embolization of neovessels around the knee |
Sham Comparator: Sham Embolization Group
Group undergoes sham embolization
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Procedure: Sham embolization
Sham transcatheter arterial embolization of neovessels in the knee |
- KOOS pain sub score [ Time Frame: 4 months ]KOOS pain sub score after 4 months
- Total KOOS [ Time Frame: 1,4,8,12 month(s) ]Total KOOS result
- painDETECT questionnaire [ Time Frame: 1,4,8,12 month(s) ]painDETECT questionnaire results
- ICOAP questionnaire [ Time Frame: 1,4,8,12 month(s) ]ICOAP questionnaire results
- Pain Score 0-10 Numerical Rating Scale (NRS) [ Time Frame: 1,4,8,12 month(s) ]
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").
- EQ-5D-5L questionnaire [ Time Frame: 1,4,8,12 month(s) ]EQ-5D-5L questionnaire results
- Pressure pain threshold testing [ Time Frame: 1,4,8,12 month(s) ]Pressure pain threshold testing results
- Knee MRI [ Time Frame: 1 and 4 month(s) ]Knee MRI scan results

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884049
Contact: Edwin Oei, MD, PhD | 31 10 7040619 | e.oei@erasmusmc.nl | |
Contact: Tijmen A Zadelhof, PhD student | 31 10 7030420 | t.vanzadelhoff@erasmusmc.nl |
Netherlands | |
ErasmusMC | Recruiting |
Rotterdam, Zuid Holland, Netherlands, 3015CE |
Principal Investigator: | Edwin Edwin, MD, PhD | Erasmus Medical Center | |
Principal Investigator: | Adriaan Moelker, MD, PhD | Erasmus Medical Center |
Responsible Party: | Dr. Edwin Oei, Principal investigator, Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT03884049 |
Other Study ID Numbers: |
METC 2018-081 2018-081 ( Registry Identifier: METC ErasmusMC ) |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | July 30, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Not as yet. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ranscatheter embolization osteoarthritis arterial |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |