Symptomatic Efficacy of Microparticle Arterial Embolization in Knee Osteoarthritis Resistant to Medical Treatment

NCT03460665 | Completed

• 1 other identifier: 18-PP-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this double-blind, randomized, single-center prospective study (patient and evaluator) is to evaluate the efficacy of arterial occlusion (embolization) of neovessels by microparticle versus placebo on pain in disabling knee osteoarthritis at 12 months.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• VAS : Change of pain of the Knee injury

  change in the Visual Analog Scale of Pain Intensity (VASPI).

  before intervention and one month, 6 months, 12 months, 24 months and 36 months after intervention

Secondary Outcomes (4)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  at 1,6, 24, 36 month after intervention

• EQ-5D questionnaire

  at 1, 6, 12 and 36 month after intervention

• Knee MRI

  15 days before embolization and 12 month after

• Knee X-Ray

  15 days before embolization and 12, 24, 36 month after

Study Arms (2)

Microparticles

EXPERIMENTAL

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

Procedure: Arteriography

Placebo

PLACEBO COMPARATOR

knee arteriography and injection of saline solution in neovessels

Procedure: Arteriography

Interventions

Arteriography PROCEDURE

knee arteriography

Microparticles; Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An effective contraceptive system for women of childbearing age, a pregnancy test will be offered to these women in the preoperative assessment.
• Obtaining the signature of the consent to participate in the study
• Kellgren-Lawrence (KL) grade 2-3 assessed by routine weight-bearing knee radiographs on the most affected knee in bilateral cases
• Pain with EVA ≥ 50 mm evolving for at least 3 months despite the start of a well-conducted medical treatment according to current recommendations including analgesics, NSAID, intra-articular injections, rehabilitation and weight loss
• No surgical indication retained

You may not qualify if:

• Serious visceral failure
• Local infection
• Arthropathy secondary to chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis) or microcrystalline rheumatism
• History of surgery on the studied knee, except arthroscopy for more than 6 months
• Gonarthrosis with KL score\> 3
• Osteonecrosis of one of the bones of the knee joint on the MRI
• Pregnant or lactating woman
• Allergy to contrast products
• Chronic or acute renal failure (clearance \<30 ml / min)
• Haemostasis disorders (blood platelet count \<50,000 / mm3 or patient ACT / control ACT\> 1,2 or PT \<50%)
• Operative indication of placement of a prosthesis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

chu Bordeaux

Bordeaux, France

Location

BREUIL

Nice, 06000, France

Location

Chu de Nimes

Nîmes, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yves CHAU HUU DANH, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: March 9, 2018
• Study Start: October 4, 2018
• Primary Completion: October 4, 2021
• Study Completion: January 29, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)