Clinical trial NCT04566315: EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT
Official title: SYMPTOMATIC EFFECTIVENESS OF MICROPARTICLE ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate at 3 months in a prospective study, the effectiveness of arterial embolization of neo-vessels in patients with a painful total knee prosthesis despite a well-conducted medical treatment

Detailed description: To date, no study has attempted to measure the effects of arterial embolization on pain in patients with total knee prosthesis. It would be interesting to evaluate, in a therapeutic trial with a good level of evidence, this alternative to drug treatments that are often poorly tolerated, contraindicated or failing in this population of elderly subjects often presenting co-morbidities. This pilot study will be used to calculate the number of patients to be included in a comparative, placebo-controlled, double-blind study. In addition to the evaluation of the undesirable effects of arterial embolization, the objective of this study is to evaluate the effectiveness at 3 and 6 months of embolization of the neovessels on pain, stiffness, physical activity, quality of life and consumption of analgesics and anti-inflammatories.

Evaluation criteria: modification of the pain item in the EVA (Analog Visual Scale), EQ-5D (quality of life scale), and Knee injury and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected in the 15 days preceding the procedure and then at 3 and 6 months ; the use of analgesics and anti-inflammatories; adverse events.

Study population: Patients aged 40 to 80 years with a painful total knee joint. The visual analogue scale (VAS) score must be greater than or equal to 50 mm for at least 3 months optimal medical treatment, and for whom, no surgical retreatment is indicated.

The expected benefits are the improvement of the treatment of patients in therapeutic impasse, wearing a total knee prosthesis whose pain is rebellious and disabling. More generally, the investigators expect an improvement in the quality of life of these patients currently without satisfactory alternative care.

Eligibility criteria: Inclusion Criteria:

* Man or woman aged 40 to 80.
* Total knee joint or bilateral Pain with EVA ≥ 50 mm evolving for at least 3 months despite the initiation of a well conducted medical treatment according to current recommendations including analgesics, NSAIDs, rehabilitation and weight loss

Exclusion Criteria:

* Minor person.
* Protected adults under the law. Patients deprived of their liberties. Subject not cooperative or unable to meet the requirements of the protocol.
* Subject participating in another clinical trial or in period of exclusion from a previous clinical trial. Severe visceral failure.
* Local infection. Algoneurodystrophy.
* Prosthesis loosening.
* Pregnant or breastfeeding woman.
* Allergy to contrast media.
* Chronic or acute renal failure (clearance \<30 ml / min).
* Hemostasis disorders (blood platelet count \<50,000 / mm3 or patient TCA / control TCA\> 1.2 or TP \<50%).
* Operative indication for removal of the retained prosthesis.
* Patient with obliterating arterial disease of the lower limbs.
* Contraindication to lidocaine: Known hypersensitivity to lidocaine hydrochloride, to local amide anesthetics or to any of the excipients.
* Patients with recurrent porphyria

Primary outcomes:
measure: Knee injury self-questionnaire
timeFrame: in the 15 days preceding the procedure
measure: Knee injury self-questionnaire
timeFrame: at 3 months
measure: Osteoarthritis Outcome Score (KOOS) self-questionnaire
timeFrame: in the 15 days preceding the procedure
measure: Osteoarthritis Outcome Score (KOOS) self-questionnaire
timeFrame: at 3 months
Secondary outcomes:
measure: EVA (Analog Visual Scale)
timeFrame: in the 15 days preceding the procedure ,
measure: EVA (Analog Visual Scale)
timeFrame: at 3 months
measure: EVA (Analog Visual Scale)
timeFrame: at 6 months
measure: Osteoarthritis Outcome Score (KOOS) self-questionnaire
timeFrame: in the 15 days preceding the procedure,
measure: Osteoarthritis Outcome Score (KOOS) self-questionnaire
timeFrame: at 3 months,
measure: Osteoarthritis Outcome Score (KOOS) self-questionnaire
timeFrame: at 6 months,
measure: EQ-5D (quality of life scale)
timeFrame: in the 15 days preceding the procedure
measure: EQ-5D (quality of life scale)
timeFrame: at 3 months,
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Chu de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Jacques Sedat, MD
role: PRINCIPAL_INVESTIGATOR
References: