AzTrials
AzTrials

Knee OsteoarthritisPhase 1LipioJoint1NCT04733092

Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)

A Phase 1 study testing Lipiodol in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Knee osteoarthritis is a common cause of disability in patients who are often young and active. Surgery being an option only for the most severe cases, there is little alternative in case of failure of recommended medication. Inflammatory hypervascularization of the joint is a known source of pain. Read more about this study

Who is it for?
Ages 35 to 90 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Lipiodol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteFrance
Study dates
3 Mar 2021to 20 Sep 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of primary inflammatory knee osteoarthritis of the target joint defined by a knee osteoarthritis according to the American College of Rheumatology (ACR) classification and a score ≥ 2 according to the classification of Kellgren and Lawrence
  • Patient not eligible for surgery (or refusing surgery)
  • Analog Visual Scale (VAS) pain ≥ 40 mm despite analgesic treatment for at least 3 months
  • Failure or intolerance of treatment with NSAIDs and/or tramadol and/or acetaminophen, and/or failure or intolerance or patient refusing strong opioids medication (morphine, codeine)
  • Failure or patient refusal of corticosteroid infiltration
  • Patient who has signed an informed consent

Who cannot join

  • Patient who is unable or unable to comply with the follow-up schedule
  • Infiltration of target joint less than three months old
  • Treated hyperthyroidism
  • Traumatic injury, hemorrhage or bleeding less than 1 week old in the target joint
  • Known arterial disease of the lower limbs stage ≥ 2 according to the classification of Leriche and Fontaine
  • Known severe allergy to Lipiodol® and/or iodized contrast product
Show all 11Show fewer
  • Known severe kidney failure (creatinine clearance < 30 ml/min)
  • Pregnant or breastfeeding woman
  • Patient not affiliated with a French Medicare
  • Patient benefiting from legal protection
  • Participation in another interventional research

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital européen Georges Pompidou

    Paris, 75015

Other trials in France

About this study

Official title: Prospective Study of the Safety and Efficacy of the Use of a Lipiodol Emulsion for the Embolization of Inflammatory Hypervascularizations Observed in Patients With Joint or Abarticular Knee Pain

Knee osteoarthritis is a common cause of disability in patients who are often young and active. Surgery being an option only for the most severe cases, there is little alternative in case of failure of recommended medication. Inflammatory hypervascularization of the joint is a known source of pain. Temporary embolization of intra-arterial inflammatory hypervascularization has been used since 2012 with good results on pain relief to treat patients with musculoskeletal disorders that are resistant to conventional treatments. Lipiodol® has transient embolizing properties when in emulsion with a contrast agent. It has been used as an emulsion with chemotherapy for the treatment of metastases and primary intra-arterial liver cancer (chemo-embolization) for many years without serious side effects. We hypothesized that Lipiodol® in emulsion could serve as a temporary embolization agent for the treatment of inflammatory hypervascularization responsible for musculoskeletal disorders in humans.

Read the detailed description

It is a Phase 1, Single-Arm, Open-label, Multicenter Interventional Prospective Study.

In order to ensure the best possible patient safety, a sequential inclusion of the first 6 patients is planned. Thus, the inclusion of each subsequent patient (patient 2-6) will only be considered after reviewing previously included patient safety data. Safety data after the inclusion of each patient (after a step-back of at least one week), as well as the cumulative review of previously included patient safety data, will be brought to the attention of all investigators involved in this research.

In addition, the following information will be transmitted to the Competent Authority without delay:

  • a review of the safety and efficacy of the first 3 patients included with a step back for the last patient of at least one week after the administration of the experimental drug, as well as an argument as to the continuation of this research with regard to these data, with a discussion of the risks incurred in relation to the expected profit
  • a review of the safety and effectiveness of the first 3 patients after the inclusion of the first 6 patients, as well as an argument as to the continuation of this research with regard to these data, with a discussion of the risks incurred compared to the expected benefit.

The patients will be embolized by the Interventional Radiology Department of the European Hospital Georges Pompidou (HEGP). Embolization will be performed by an experienced radiologist during a conventional hospitalization or a day hospitalization. A clinical follow-up will be carried out at 1 week, 1 month and 3 months after embolization by clinics and patient self-assessment (WOMAC, SF-36).

Being tested
Lipiodol
Keywords
Lipiodol, musculoskeletal disorders, embolization
Medical subject headings
Osteoarthritis, Knee, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LipiodolDrug

    Also called Optiray

    Lipiodol in emulsion with contrast agent

Study groups in NCT04733092
Study groupRoleWhat they receive
EmbolizationExperimentalEmbolization of the inflammatory hypervascularization with a lipiodol emulsion
Receives: Drug: Lipiodol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious Adverse Events (SAE)

    Number of SAE related to Embolization

    Measured: 1 month

Secondary outcomes (14)

  1. Immediate Technical success

    Success of catheterization and embolization of target hypervascularization

    Measured: Intraoperative

  2. Pain improvement 1 week after embolization

    Analog Visual Scale score (0-100) comparison to baseline VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The Scale is rated from 0 to 100 (no pain to extremely severe pain)

    Measured: 1 week

  3. Pain improvement 1 month after embolization

    Analog Visual Scale score (0-100) comparison to baseline VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The Scale is rated from 0 to 100 (no pain to extremely severe pain)

    Measured: 1 month

  4. Pain improvement 3 month after embolization

    Analog Visual Scale score (0-100) comparison to baseline VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The Scale is rated from 0 to 100 (no pain to extremely severe pain)

    Measured: 3 months

  5. Articular impotence improvement 1 week after embolization

    Western Ontario and McMaster Universities Osteoarthritis Index score (0-96) comparison to baseline

    Measured: 1 week

  6. Articular impotence improvement 1 month after embolization

    Western Ontario and McMaster Universities Osteoarthritis Index score (0-96) comparison to baseline

    Measured: 1 month

  7. Articular impotence improvement 3 month after embolization

    Western Ontario and McMaster Universities Osteoarthritis Index score (0-96) comparison to baseline

    Measured: 3 months

  8. Quality of life improvement 3 month after embolization

    Short Form Health Survey (SF-36) score comparison to baseline SF-36 consists of eight scaled scores which are the weighted sums of the questions in their section, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: 3 months

  9. Pain medication improvement 1 week after embolization

    Dose of analgesic medication compared to baseline (mg/24h)

    Measured: 1 week

  10. Pain medication improvement 1 month after embolization

    Dose of analgesic medication compared to baseline (mg/24h)

    Measured: 1 month

  11. Pain medication improvement 3 month after embolization

    Dose of analgesic medication compared to baseline (mg/24h)

    Measured: 3 months

  12. Patient's satisfaction

    Patient's satisfaction questionnaire : qualitative questionnaire with 5 ordered modalities (0 = no to 4 = yes)

    Measured: 3 months

  13. Adverse Events (AE)

    Number of AE related to embolization

    Measured: 3 months

  14. Serious Adverse Events (SAE)

    Number of SAE related to embolization

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2021
  2. Study start3 Mar 2021
  3. Primary completion20 Jun 2022
  4. Study completion20 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04733092
Sponsor's protocol ID
APHP190891
Other IDs
2020-002206-10
Acronym
LipioJoint1
Status last verified
Aug 2023
First submitted
24 Jan 2021
Last updated
3 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

Publications

  • Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14.

    PubMed 38102013

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lipiodol in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events (SAE) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04733092, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in