Actively Recruiting

Phase 1
Phase 2
Age: 40Years +
All Genders
NCT06611007

Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment

Led by University Hospital, Grenoble · Updated on 2026-05-05

15

Participants Needed

1

Research Sites

180 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate the safety of arterial embolization using Lipiodol® in patients with symptomatic hand osteoarthritis refractory to conventional treatment. It will also learn about the efficacy of arterial embolization with Lipiodol® in reducing pain and improving hand function. The main questions it aims to answer are: * What are the side effects and complications associated with the Lipiodol® arterial embolization procedure? * Does arterial embolization reduce pain intensity and improve hand function? Researchers will evaluate patients over a 6-month period to assess the safety of Lipiodol® embolization and its impact on joint pain, swelling, and functional capacity. Participants will: * Undergo arterial embolization with Lipiodol® * Participate in regular follow-ups to monitor pain relief, hand function, and any side effects * Have imaging studies to assess changes in joint vascularisation and damage

CONDITIONS

Official Title

Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 60 years.
  • Osteoarthritis of the hand diagnosed by American College of Rheumatology 1990 criteria.
  • Osteoarthritis affecting at least two proximal and/or distal interphalangeal joints with radiological Kellgren-Lawrence stage 62.
  • Symptomatic osteoarthritis within the last 3 months.
  • Visual analogue pain scale of the hand to be treated 60/100 mm.
  • Inadequate response, adverse effects and/or contraindication to NSAIDs and non-opioid analgesics.
  • Patient affiliated to French social security or similar health insurance.
Not Eligible

You will not qualify if you...

  • Allergy to iodinated contrast media, Lipiodol® or poppies.
  • Vasomotor disorders such as Raynaud's syndrome, scleroderma, acrocyanosis.
  • Stenosis (>50%) or known atheromatous arterial occlusion of the upper limbs.
  • Obliterative arterial disease of the lower limbs at the critical ischemia stage.
  • Severe to end-stage chronic renal insufficiency (glomerular filtration rate <30ml/min/1.73m2), dialysis or renal transplant.
  • Arteritis such as thromboangiitis obliterans or other diseases.
  • Previous thrombosis or dissection of the radial artery.
  • Chronic inflammatory rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, microcrystalline arthritis, etc.).
  • Known hyperthyroidism or large multinodular goiter.
  • Traumatic lesions, hemorrhages or chronic bleeding in the hand not resolved within 3 months requiring embolization.
  • Pregnant or breastfeeding.
  • Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code or who do not speak French.
  • Patients currently in exclusion period or enrolled in another interventional clinical trial.

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Grenoble Alpes - Sud site

Échirolles, France, 38130

Actively Recruiting

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Research Team

X

Xavier Romand, MD, PhD

CONTACT

E

Emeric Gremen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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