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Clinical Trials/EUCTR2020-002206-10-FR
EUCTR2020-002206-10-FR
Active, not recruiting
Phase 1

A prospective study of the safety and efficacy of the use of a Lipiodol Emulsion for the embolization of inflammatory hypervascularizations observed in patients with articular or abarticular pain in the knee - LipioJoint 1 - LipioJoint 1

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 sites22 target enrollmentApril 30, 2020

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Enrollment
22
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 30, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • \-age between 18 and 90 years included
  • \-diagnosis of primary inflammatory knee osteoarthritis defined by an osteoarthritis according to the classification of the ACR (American College of Rheumatology) and a score \= 2 according to the classification of Kellgren and Lawrence
  • \-patient not eligible for surgery (or refusing surgery)
  • \-pain \= 40 mm (Analog Visual Scale) despite an analgesic medication for at least 3 months
  • \-failure or intolerance of treatment with NSAIDs and/or tramadol and/or paracetamol, and/or failure or intolerance or patient unwilling a strong opioid treatment (morphinic, codeine)
  • \-failure or refusal by the patient of corticosteroid infiltration
  • \-patient who has signed an informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • \-patient unable or unwilling to comply with the follow\-up schedule
  • \-infiltration in target joint within the previous three months
  • \- treated hyperthyroidism
  • \-traumatic injury, hemorrhage or bleeding in the target joint within the last week
  • \-known severe allergy to Lipiodol® and/or iodized contrast medium
  • \-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 study

Outcomes

Primary Outcomes

Not specified

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