A Phase 1/2 interventional study of embolization therapy in Osteoarthritis, sponsored by University Hospital, Grenoble. Recruiting at 1 site in France. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University Hospital, Grenoble · Phase 1/2, Interventional, and Treatment
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:
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:
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 15 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
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Exclusion Criteria:
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
Hand arterial embolization with Lipiodol in emulsion with iodinated contrast agent
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).
Time frame: From embolization to 6 months after embolization
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 1
Percentage of patients with at least a 50% improvement in pain on the pain Analog Visual Scale score (0-100) of the treated hand compared to baseline, at month 1. VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The VAS is rated from 0 to 100 (no pain to extremely severe pain).
Time frame: baseline and month 1
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 3
Percentage of patients with at least a 50% improvement in pain on the pain Analog Visual Scale score (0-100) of the treated hand compared to baseline, at month 3. VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The VAS is rated from 0 to 100 (no pain to extremely severe pain).
Time frame: Baseline and Month 3
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 6
Percentage of patients with at least a 50% improvement in pain on the pain Analog Visual Scale score (0-100) of the treated hand compared to baseline, at month 1. VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The VAS is rated from 0 to 100 (no pain to extremely severe pain).
Time frame: Baseline and Month 6
Change From Baseline in Swollen Joints Counts at Month 1
Swollen joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Time frame: Baseline and Month 1
Change From Baseline in Swollen Joints Counts at Month 3
Swollen joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Time frame: Baseline and Month 3
Change From Baseline in Swollen Joints Counts at Month 6
Swollen joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Time frame: Baseline and Month 6
Change From Baseline in Tender Joints Counts at Month 1
Tender joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Time frame: Baseline and Month 1
Change From Baseline in Tender Joints Counts at Month 3
Tender joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Time frame: Baseline and Month 3
Change From Baseline in Tender Joints Counts at Month 6
Tender joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Time frame: Baseline and Month 6
Change From Baseline in Cochin Hand Function Index score at Month 1
Cochin Hand Function Index Score is a functional disability scale for hand comprising 18 questions on daily activities. This question is completed by the patient. Final score is obtained by adding the score of each question rated on a Likert scale from 0 (done without difficulty) to 5 (impossible to do).
Time frame: From Baseline and Month 1
Change From Baseline in Cochin Hand Function Index score at Month 3
Cochin Hand Function Index Score is a functional disability scale for hand comprising 18 questions on daily activities. This question is completed by the patient. Final score is obtained by adding the score of each question rated on a Likert scale from 0 (done without difficulty) to 5 (impossible to do).
Time frame: From Baseline and Month 3
Change From Baseline in Cochin Hand Function Index score at Month 6
Cochin Hand Function Index Score is a functional disability scale for hand comprising 18 questions on daily activities. This question is completed by the patient. Final score is obtained by adding the score of each question rated on a Likert scale from 0 (done without difficulty) to 5 (impossible to do).
Time frame: From Baseline and Month 6
Change From Baseline in Functional Index for Hand Osteoarthritis at Month 1
The Functional Index for Hand Osteoarthritis (FIHOA) assesses hand osteoarthrits-related functional impairment scoring from 0 (no functional impairment) to 30 points (maximal impairment).
Time frame: From Baseline and Month 1
Change From Baseline in Functional Index for Hand Osteoarthritis at Month 3
The Functional Index for Hand Osteoarthritis (FIHOA) assesses hand osteoarthrits-related functional impairment scoring from 0 (no functional impairment) to 30 points (maximal impairment).
Time frame: From Baseline and Month 3
Change From Baseline in Functional Index for Hand Osteoarthritis at Month 6
The Functional Index for Hand Osteoarthritis (FIHOA) assesses hand osteoarthrits-related functional impairment scoring from 0 (no functional impairment) to 30 points (maximal impairment).
Time frame: From Baseline and Month 6
Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 1
The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) is a shortened version of the DASH questionnaire, designed to evaluate upper limb function and symptoms. It consists of 11 questions that measure physical function and symptoms related to daily activities, work, and leisure. Each item is scored on a 5-point scale, with higher scores indicating greater disability. The final score is calculated in accordance with the following formula: =((sum of n responses/n)-1)x25, where n represents the number of completed responses.
Time frame: From Baseline and Month 1
Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 3
The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) is a shortened version of the DASH questionnaire, designed to evaluate upper limb function and symptoms. It consists of 11 questions that measure physical function and symptoms related to daily activities, work, and leisure. Each item is scored on a 5-point scale, with higher scores indicating greater disability. The final score is calculated in accordance with the following formula: =((sum of n responses/n)-1)x25, where n represents the number of completed responses.
Time frame: From Baseline and Month 3
Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 6
The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) is a shortened version of the DASH questionnaire, designed to evaluate upper limb function and symptoms. It consists of 11 questions that measure physical function and symptoms related to daily activities, work, and leisure. Each item is scored on a 5-point scale, with higher scores indicating greater disability. The final score is calculated in accordance with the following formula: =((sum of n responses/n)-1)x25, where n represents the number of completed responses.
Time frame: From Baseline and Month 6
Change from Baseline in Hand grip strength at Month 1
Grip strength of the hand is assessed using a Grip Strength Hand Dynamometer. The result is expressed in kilograms.
Time frame: Baseline and Month 1
Change from Baseline in Hand grip strength at Month 3
Grip strength of the hand is assessed using a Grip Strength Hand Dynamometer. The result is expressed in kilograms.
Time frame: Baseline and Month 3
Change from Baseline in Hand grip strength at Month 6
Grip strength of the hand is assessed using a Grip Strength Hand Dynamometer. The result is expressed in kilograms.
Time frame: Baseline and Month 6
Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 1
Doppler vascularisation was assessed using a semi-quantitative score (0-3, 0: no vascularisation, 3: high vascularisation) in acccordance with OMERACT guidelines.
Time frame: Baseline and Month 1
Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 3
Doppler vascularisation was assessed using a semi-quantitative score (0-3, 0: no vascularisation, 3: high vascularisation) in acccordance with OMERACT guidelines.
Time frame: Baseline and Month 3
Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 6
Doppler vascularisation was assessed using a semi-quantitative score (0-3, 0: no vascularisation, 3: high vascularisation) in acccordance with OMERACT guidelines.
Time frame: Baseline and Month 6
Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 1
Synovitis was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no synovitis, 3: significant synovitis) in acccordance with OMERACT guidelines.
Time frame: Baseline and Month 1
Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 3
Synovitis was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no synovitis, 3: significant synovitis) in acccordance with OMERACT guidelines.
Time frame: Baseline and Month 3
Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 6
Synovitis was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no synovitis, 3: significant synovitis) in acccordance with OMERACT guidelines.
Time frame: Baseline and Month 6
Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 1
Joint effusion was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no joint effusion, 3: high joint effusion) in acccordance with OMERACT guidelines.
Time frame: Baseline and Month 1
Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 3
Joint effusion was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no joint effusion, 3: high joint effusion) in acccordance with OMERACT guidelines.
Time frame: Baseline and Month 3
Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 6
Joint effusion was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no joint effusion, 3: high joint effusion) in acccordance with OMERACT guidelines.
Time frame: Baseline and Month 6
Change from 6 months prior to inclusion in use of pain medication over the 6 months of study
Pain medication will be described using analgesic level.
Time frame: From 6 months before inclusion to Month 6
Change in the intensity of neovascularisation in the hand joints, as assessed by arteriography, from before embolisation to immediately after embolisation
A semi-quantitative assessment of neovascularisation (weak/moderate/important) before and after embolisation of the treated hand by analysing vascuralisation throw angiography is performed The following joints are evaluated : Trapezium-metacarpal joint, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, distal interphalangeal (DIP) joints 2-5.
Time frame: Before and Immediately after embolisation
Change From Baseline in Ghent University Scoring System (GUSS) at Month 6
The Ghent University Scoring System (GUSS) is a radiographic scoring method specifically developed to evaluate joint damage in hand osteoarthritis. It focuses on assessing both structural damage and remodeling features visible on hand X-rays. Erosive progression and signs of repair or remodelling are scored by indicating the proportion of normal subchondral bone, subchondral plate and joint space on an 11-point rating scale (range 0-100 with 10 unit increases). A lower score indicates greater damage or remodeling. The total score is the sum of these 3 scores for the joint under consideration.
Time frame: Baseline and Month 6
Change in hand cutaneous microcirculation assessed by Laser Speckle Contrast Imaging (LSCI) before and during two hours post embolization
A PeriCam PSI device (Perimed, Sweden) will be used to assess skin perfusion in both hands. The image size will be set at 30 x 20 centimetres and the acquisition speed at one image per second. The wavelength chosen will be 785 nm and the laser head will be positioned between 15 and 20 centimetres above the hands (with a resolution of \~ 6.9 pixels/ cm2). Cutaneous blood flow in the areas of interest will be expressed as PU (perfusion unit) and/or CVC (cutaneous vascular conductance). The area of interest will be the whole hand and the area around each hand joint.
Time frame: Before embolisation and 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post embolisation
Plan to share: Yes — Access to anonymized individual data and other informations as study protocole, informed consent form, clinical study report.
Supporting information: Study protocol, Icf, Csr, Analytic code
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University Hospital, Grenoble