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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    90
  • sponsor
    Centre Hospitalier Universitaire de Nice
Updated on 22 January 2021
osteoarthritis
NSAID
intra-articular injection

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.

Description

Rational: in the normal state, the articular cartilage is devoid of vessels and innervation. In osteoarthritic cartilage, neovascularization is observed and is accompanied by a sensitive neoinnervation. The development of these neovessels also contributes to the structural damage of cartilage by achieving a real "perforation"of the cartilage. Studies designate neovascularization as a target for new therapeutic. In two non-comparative open-label studies, a Japanese team has shown that endovascular occlusion of these neovessels in patients with knee osteoarthritis significantly reduced the patient pain without any complication.

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.

The main objective is to evaluate the effectiveness of embolization on the pain of patients with disabling osteoarthritis by double-blind comparison of two groups: the first control group will include patients who will benefit from arteriography and an injection of saline in their neovessels, the second group called treatment will consist of patients whose neovessels will be occluded by inert microparticles of 75 m. The pain will be evaluated in both groups before and 12 months after embolisation. The objective is to show that the pain is significantly less important in the group of patients whose neovessels have been occluded with microparticles in comparison to the control group.

Secondary objectives are to evaluate the effectiveness of neovascular embolization on pain at 1, 6, 24 and 36 months; knee stiffness, physical activity, quality of life, at 1, 6, 12, 24 and 36 months; the structural course of knee osteoarthritis at 12, 24 and 36 months; the use of arthroplasty at 24 and 36 months.

Study Population: Patients aged 40 to 80 years with knee osteoarthritis with a visual analogue scale (VAS) score greater than or equal to 50 mm for at least 3 months optimal medical treatment, whose radiological stage of osteoarthritis according to Kellgren and Lawence is 2 or 3 and does not have a knee prosthesis surgical indication.

Primary endpoint: modification of the pain item of the self-administered Knee injury and Osteoarthritis Outcome Score (KOOS) collected in the 15 days preceding the procedure and at 12 months.

Secondary evaluation criteria are KOOS, EQ-5D (Quality of Life Scale) in the 15 days preceding the procedure and then at 1, 6, 24 and 36 months; knee radiographs, number of patients who had 12, 24 and 36 months of joint replacement surgery; knee MRI at 12 months; the use of analgesics and anti-inflammatories; adverse events.

Expected benefits: confirm the results of the non-randomized studies that showed a clear decrease in pain related to knee osteoarthritis after occlusion of neovessels, allowing the reduction of antalgic drug consumption, improving the quality of life of patients of this pathology, delay the need for prosthetic surgery.

Details
Condition Osteoarthritis of knee, Osteoarthritis, Gonarthrosis, knee osteoarthritis
Treatment arteriography
Clinical Study IdentifierNCT03460665
SponsorCentre Hospitalier Universitaire de Nice
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 40 yrs and 80 yrs?
Gender: Male or Female
Do you have Osteoarthritis of knee?
Do you have any of these conditions: Osteoarthritis or Gonarthrosis or knee osteoarthritis or Osteoarthritis of knee?
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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note