Clinical trial NCT06611007: Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment
Official title: Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Keywords: Therapeutic embolization
Safety
Hand osteoarthritis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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\&#39;s syndrome, scleroderma, acrocyanosis).
* Stenosis (\&gt;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 \&lt; 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.

Primary outcomes:
measure: Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE
timeFrame: From embolization to 6 months after embolization
Secondary outcomes:
measure: Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 1
timeFrame: baseline and month 1
measure: Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 3
timeFrame: Baseline and Month 3
measure: Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Swollen Joints Counts at Month 1
timeFrame: Baseline and Month 1
measure: Change From Baseline in Swollen Joints Counts at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in Swollen Joints Counts at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Tender Joints Counts at Month 1
timeFrame: Baseline and Month 1
measure: Change From Baseline in Tender Joints Counts at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in Tender Joints Counts at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Cochin Hand Function Index score at Month 1
timeFrame: From Baseline and Month 1
measure: Change From Baseline in Cochin Hand Function Index score at Month 3
timeFrame: From Baseline and Month 3
measure: Change From Baseline in Cochin Hand Function Index score at Month 6
timeFrame: From Baseline and Month 6
measure: Change From Baseline in Functional Index for Hand Osteoarthritis at Month 1
timeFrame: From Baseline and Month 1
measure: Change From Baseline in Functional Index for Hand Osteoarthritis at Month 3
timeFrame: From Baseline and Month 3
measure: Change From Baseline in Functional Index for Hand Osteoarthritis at Month 6
timeFrame: From Baseline and Month 6
measure: Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 1
timeFrame: From Baseline and Month 1
measure: Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 3
timeFrame: From Baseline and Month 3
measure: Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 6
timeFrame: From Baseline and Month 6
measure: Change from Baseline in Hand grip strength at Month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline in Hand grip strength at Month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline in Hand grip strength at Month 6
timeFrame: Baseline and Month 6
measure: Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 6
timeFrame: Baseline and Month 6
measure: Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 6
timeFrame: Baseline and Month 6
measure: Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 6
timeFrame: Baseline and Month 6
measure: Change from 6 months prior to inclusion in use of pain medication over the 6 months of study
timeFrame: From 6 months before inclusion to Month 6
measure: Change in the intensity of neovascularisation in the hand joints, as assessed by arteriography, from before embolisation to immediately after embolisation
timeFrame: Before and Immediately after embolisation
measure: Change From Baseline in Ghent University Scoring System (GUSS) at Month 6
timeFrame: Baseline and Month 6
measure: Change in hand cutaneous microcirculation assessed by Laser Speckle Contrast Imaging (LSCI) before and during two hours post embolization
timeFrame: Before embolisation and 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post embolisation
Other outcomes:
Locations:
city: Echirolles
country: France
facility: CHU Grenoble Alpes - Sud site
Study officials:
affiliation: CHU Grenoble Alpes, site Sud, France
name: Xavier Romand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: