NCT04566315

Brief Summary

The objective of this study is to evaluate at 3 months in a prospective study, the effectiveness of arterial embolization of neo-vessels in patients with a painful total knee prosthesis despite a well-conducted medical treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable knee-osteoarthritis

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

July 24, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2022

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

July 24, 2020

Last Update Submit

January 11, 2024

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • Knee injury self-questionnaire

    modification of the pain item in the Knee injury self-questionnaire collected

    in the 15 days preceding the procedure

  • Knee injury self-questionnaire

    modification of the pain item in the Knee injury self-questionnaire collected

    at 3 months

  • Osteoarthritis Outcome Score (KOOS) self-questionnaire

    and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected

    in the 15 days preceding the procedure

  • Osteoarthritis Outcome Score (KOOS) self-questionnaire

    and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected

    at 3 months

Secondary Outcomes (8)

  • EVA (Analog Visual Scale)

    in the 15 days preceding the procedure ,

  • EVA (Analog Visual Scale)

    at 3 months

  • EVA (Analog Visual Scale)

    at 6 months

  • Osteoarthritis Outcome Score (KOOS) self-questionnaire

    in the 15 days preceding the procedure,

  • Osteoarthritis Outcome Score (KOOS) self-questionnaire

    at 3 months,

  • +3 more secondary outcomes

Study Arms (1)

ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS

OTHER

SYMPTOMATIC EFFECTIVENESS OF MICROPARTICLE ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT

Procedure: Arteriography knee arteriography

Interventions

Arteriography knee arteriographyPROCEDURE

arteriography and an injection of inert microparticles of 75 μm in neovessels

ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman aged 40 to 80.
  • Total knee joint or bilateral Pain with EVA ≥ 50 mm evolving for at least 3 months despite the initiation of a well conducted medical treatment according to current recommendations including analgesics, NSAIDs, rehabilitation and weight loss

You may not qualify if:

  • Minor person.
  • Protected adults under the law. Patients deprived of their liberties. Subject not cooperative or unable to meet the requirements of the protocol.
  • Local infection. Algoneurodystrophy.
  • Prosthesis loosening.
  • Pregnant or breastfeeding woman.
  • Allergy to contrast media.
  • Chronic or acute renal failure (clearance \<30 ml / min).
  • Hemostasis disorders (blood platelet count \<50,000 / mm3 or patient TCA / control TCA\> 1.2 or TP \<50%).
  • Operative indication for removal of the retained prosthesis.
  • Patient with obliterating arterial disease of the lower limbs.
  • Contraindication to lidocaine: Known hypersensitivity to lidocaine hydrochloride, to local amide anesthetics or to any of the excipients.
  • Patients with recurrent porphyria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, CHU de NICE, 06003, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jacques Sedat, MD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

September 28, 2020

Study Start

January 6, 2021

Primary Completion

July 6, 2021

Study Completion

September 7, 2022

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)