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

NCT ID: NCT06611007

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2028-07-15

Brief 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

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arterial embolization of the hand with Lipiodol

The radial artery will be embolized with Lipiodol emulsified 3:1 with iodinated contrast medium (Optiray 300 mg/ml). The most painful hand according to VAS pain will be treated.

Group Type: EXPERIMENTAL

embolization therapy

Intervention Type: DRUG

Hand arterial embolization with Lipiodol in emulsion with iodinated contrast agent

Interventions

embolization therapy

Hand arterial embolization with Lipiodol in emulsion with iodinated contrast agent

Intervention Type: DRUG

Eligibility Criteria

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 joints with 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 painful hand).
• Inadequate response, adverse effects and/or contraindication to NSAIDs and non-opioid analgesics.
• Patient affiliated to french social security or a similar health assurance.

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 completely resolved 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 Code and/or who do not speak French.
• Patients in a period of exclusion or in the course of another interventional clinical trial.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Romand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes, site Sud, France

Locations

CHU Grenoble Alpes - Sud site

Échirolles, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Xavier Romand, MD, PhD

Role: CONTACT

xromand@chu-grenoble.fr

0476767223 ext. +33

Emeric Gremen, MD

Role: CONTACT

egremen@chu-grenoble.fr

Facility Contacts

Xavier ROMAND, MD, PHD

Role: primary

xromand@chu-grenoble.fr

0476767223

Emeric GREMEN, MD, PHD

Role: backup

egremen@chu-grenoble.fr

0476765829

Other Identifiers

2024-513361-40-00

Identifier Type: CTIS

Identifier Source: secondary_id

38RC23.0227

Identifier Type: -

Identifier Source: org_study_id