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

Last updated: January 30, 2025
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

1/2

Condition

Osteoarthritis

Treatment

Embolization therapeutic

embolization therapy

Clinical Study ID

NCT06611007
38RC23.0227
2024-513361-40-00
  • Ages > 40
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • 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 jointswith a radiological Kellgren-Lawrence stage ≥ 2.

  • Symptomatic osteoarthritis within the last 3 months.

  • Visual analogue pain scale of the hand to be treated ≥ 40/100 mm (most painfulhand).

  • Inadequate response, adverse effects and/or contraindication to NSAIDs andnon-opioid analgesics.

  • Patient affiliated to french social security or a similar health assurance.

Exclusion

Exclusion Criteria:

  • 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.

  • Severe to end-stage chronic renal insufficiency (glomerular filtration rate < 30ml/min/1.73m2), dialysis or renal transplant.

  • Arteritis such as thromboangiitis obliterans disease or other diseases

  • Previous thrombosis/dissection of the radial artery.

  • Chronic inflammatory rheumatic disease (rheumatoid arthritis, psoriatic arthritis,microcrystalline arthritis, etc.).

  • Known hyperthyroidism or large multinodular goiter.

  • Traumatic lesions, haemorrhages or chronic bleeding in the hand (not completelyresolved within 3 months of the start of the lesion) requiring embolisation.

  • Pregnant or breast-feeding.

  • Patients covered by articles L1121-5 to L1121-8 of the French Public Health Codeand/or who do not speak French.

  • Patients in a period of exclusion or in the course of another interventionalclinical trial.

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Embolization therapeutic
Phase: 1/2
Study Start date:
January 30, 2025
Estimated Completion Date:
July 15, 2028

Connect with a study center

  • CHU Grenoble Alpes - Sud site

    Echirolles, 38130
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.