Embolization of the knee arteries to relief chronic pain using imipenen/cilastatin versus microspheres

Phase 4

Recruiting

• Conditions: gonoarthrosis; 10179

• Registration Number: RBR-2h5rwgb
• Lead Sponsor: Invasc - Instituto Vascular de Passo Fundo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-20
• Study Completion: 2023-02-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of knee ostheoartritis; Knee pain for more than 6 month; Refractory to conservative treatment - at least 3 months of physical therapy and/or parenteral pain medication and/or corticosteroid knee infiltration with no clinical improvement; Kellgreen-Lawrence classification I to III in the knee X-ray; Comproved sinovitis in the magnetic resonance; Wiling to participate and to sign the consentment term; Willing to follow up; It has to be in hospital due to refractory knee pain.

Exclusion Criteria

Indication to total knee replacement, Kellgreen-Lawrence grade IV; No conservative measure performed before enrollment; Previous knee arthroplasty; Patients with Rheumatoid arthritis or infectious arthritis; Patients with fybromialgia; Deposit corticosteroid 30 days prior to embolization; Patients with no cognitive conditions to participate to the procedure, informing where are the pain areas; Comproved allergy to iodine ou to any of the embolization agents; Comproved coagulopathy; Prothrombin activity time <50%; INR >1,5; Platelet count <50.000/mm3; Serum creatinin > 2,0mg/dl; Not to sign consentment term or not to willing to participate of the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical improvement of at least 80% in symptoms after the proposed treatment, assessed using validated quality of life questionnaires. Reduction of synovitis areas on magnetic resonance imaging after one year of treatment, evaluating synovitis scores validated in the literature.

Secondary Outcome Measures

Name	Time	Method
To define the non-inferiority of one embolization agent in relation to the other