NCT03884049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 5, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

March 19, 2019

Last Update Submit

March 28, 2024

Conditions

Osteoarthritis, Knee

Keywords

ranscatheterembolizationosteoarthritisarterial

Outcome Measures

Primary Outcomes (1)

  • KOOS pain sub score

    KOOS pain sub score after 4 months

    4 months

Secondary Outcomes (7)

  • Total KOOS

    1,4,8,12 month(s)

  • painDETECT questionnaire

    1,4,8,12 month(s)

  • ICOAP questionnaire

    1,4,8,12 month(s)

  • Pain Score 0-10 Numerical Rating Scale (NRS)

    1,4,8,12 month(s)

  • EQ-5D-5L questionnaire

    1,4,8,12 month(s)

  • +2 more secondary outcomes

Study Arms (2)

Embolization group

EXPERIMENTAL

Group undergoes transcatheter arterial embolization of neovessels around the knee.

Procedure: Embolization

Sham Embolization Group

SHAM COMPARATOR

Group undergoes sham embolization

Procedure: Sham embolization

Interventions

EmbolizationPROCEDURE

transcatheter arterial embolization of neovessels around the knee

Embolization group
Sham embolizationPROCEDURE

Sham transcatheter arterial embolization of neovessels in the knee

Sham Embolization Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age.≥18 years
  • Knee pain for a duration of ≥ 6 months
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015CE, Netherlands

Location

Related Publications (2)

  • van Zadelhoff TA, Bos PK, Moelker A, Bierma-Zeinstra SMA, van der Heijden RA, Oei EHG. Genicular artery embolisation versus sham embolisation for symptomatic osteoarthritis of the knee: a randomised controlled trial. BMJ Open. 2024 Oct 1;14(10):e087047. doi: 10.1136/bmjopen-2024-087047.

    PMID: 39353688DERIVED

  • 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.

    PMID: 34998425DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Edwin Edwin, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Adriaan Moelker, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blinded randomized placebo-controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 21, 2019

Study Start

June 5, 2019

Primary Completion

May 5, 2022

Study Completion

January 30, 2023

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

We are willing the share all our available unidentified data on reasonable request

Shared Documents
STUDY PROTOCOL
Time Frame
is available upon request as of now and will be available for the next 15 years.
Access Criteria
* after written request to PI * after signing Data Transfer Agreement * No commercial use for data allowed by requesting party.

Locations

NL(1)