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

NCT06611007 | Recruiting Phase 1 DMC

• 2 other identifiers: 38RC23.02272024-513361-40-00
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Therapeutic embolization; Safety; Hand osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE

  The primary endpoint is the number and frequency of embolisation-related adverse events throughout the study period (6 months). Each adverse event will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) from grade 1 (mild) to grade 5 (fatal).

  From embolization to 6 months after embolization

Secondary Outcomes (34)

• Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 1

  baseline and month 1

• Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 3

  Baseline and Month 3

• Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 6

  Baseline and Month 6

• Change From Baseline in Swollen Joints Counts at Month 1

  Baseline and Month 1

• Change From Baseline in Swollen Joints Counts at Month 3

  Baseline and Month 3

Study Arms (1)

Arterial embolization of the hand with Lipiodol

EXPERIMENTAL

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.

Drug: embolization therapy

Interventions

embolization therapy DRUG

Hand arterial embolization with Lipiodol in emulsion with iodinated contrast agent

Arterial embolization of the hand with Lipiodol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes - Sud site

Échirolles, 38130, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Xavier Romand, MD, PhD

  CHU Grenoble Alpes, site Sud, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Romand, MD, PhD

CONTACT

0476767223; xromand@chu-grenoble.fr

Emeric Gremen, MD

CONTACT

egremen@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers to the corresponding author. The data will be shared on reasonable request after will be provided following review and approval of a research proposal and statistical analysis plan. A contract will be drawn up and signed to ensure, in particular, compliance with the RGPD rules, confidentiality.

Locations

FR (1)