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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884049
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
William Cook Europe
Stichting Coolsingel
Information provided by (Responsible Party):
Dr. Edwin Oei, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Embolization Procedure: Sham embolization Not Applicable

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. KOOS pain sub score [ Time Frame: 4 months ]
    KOOS pain sub score after 4 months


Secondary Outcome Measures :
  1. Total KOOS [ Time Frame: 1,4,8,12 month(s) ]
    Total KOOS result

  2. painDETECT questionnaire [ Time Frame: 1,4,8,12 month(s) ]
    painDETECT questionnaire results

  3. ICOAP questionnaire [ Time Frame: 1,4,8,12 month(s) ]
    ICOAP questionnaire results

  4. 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").


  5. EQ-5D-5L questionnaire [ Time Frame: 1,4,8,12 month(s) ]
    EQ-5D-5L questionnaire results

  6. Pressure pain threshold testing [ Time Frame: 1,4,8,12 month(s) ]
    Pressure pain threshold testing results

  7. Knee MRI [ Time Frame: 1 and 4 month(s) ]
    Knee MRI scan results



Information from the National Library of Medicine

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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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Netherlands
ErasmusMC Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015CE
Sponsors and Collaborators
Erasmus Medical Center
William Cook Europe
Stichting Coolsingel
Investigators
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Principal Investigator: Edwin Edwin, MD, PhD Erasmus Medical Center
Principal Investigator: Adriaan Moelker, MD, PhD Erasmus Medical Center
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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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Edwin Oei, Erasmus Medical Center:
ranscatheter
embolization
osteoarthritis
arterial
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases