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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity Hospital, Grenoble

About this trial

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

Eligibility criteria

Qualifiers

Patients aged ≥ 40 years.

Osteoarthritis of the hand according to American College of Rheumatology criteria 1990

Osteoarthritis affecting at least two proximal and/or distal interphalangeal joints with a radiological Kellgren-Lawrence stage ≥ 2.

Symptomatic osteoarthritis within the last 3 months.

Disqualifiers

History of allergy to iodinated contrast media, LipiodolⓇ or poppies.

Vasomotor disorders (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 ischaemia stage.

Trial design

Treatments tested in this trial

  • embolization therapy

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators