NCT04566315

EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT

SYMPTOMATIC EFFECTIVENESS OF MICROPARTICLE ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Arteriography knee arteriography	arteriography and an injection of inert microparticles of 75 μm in neovessels

Timeline

• Start date: 2021-01-06
• Primary completion: 2021-07-06
• Completion: 2022-09-07
• First posted: 2020-09-28
• Last updated: 2024-01-12

Locations

1 site across 1 country: France