Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Grenoble Alpes - Sud site
RECRUITING
Échirolles
Contact Information
Primary
Xavier Romand, MD, PhD
xromand@chu-grenoble.fr
0476767223
Backup
Emeric Gremen, MD
egremen@chu-grenoble.fr
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2028-07-15
Participants
Target number of participants: 15
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Grenoble

This content was sourced from clinicaltrials.gov