Embolization of the knee arteries to relief Chronic Pain using Imipenen/Cilastatin versus Microspheres

Randomized clinical trial of Genicular Artery Embolization using Imipenem/Cilasatin versus Microspheres for the treatment of Chronic Knee Pain

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-2h5rwgb

Enrollment

Unknown

Registered

2021-07-20

Start date

2021-02-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gonoarthrosis

Interventions

Non-inferiority study with two experimental groups, one genicular artery embolization with imipenem/cilastatin sand in 30 patients with gonoarthrosis and refractory pain versus another genicular arter

E02.520.360 E02.926.500

Eligibility

Inclusion criteria

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

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 1,5; Platelet count 2,0mg/dl; Not to sign consentment term or not to willing to participate of the study.

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: To evaluate the safety of genicular artery embolization for the treatment of chronic pain and inflammatory processes related to knee osteoarthritis using a temporary embolizing agent, imipenem/cilastatin, and a definitive embolizing agent, microspheres.;Outcome found 1: Embolization of the genicular arteries for the treatment of chronic pain and inflammatory processes related to osteoarthritis is safe using imipenem/cilastatin and Embospheres 100-300µm microspheres.	—

Measure

Time frame

Expected outcome 1: To evaluate the safety of genicular artery embolization for the treatment of chronic pain and inflammatory processes related to knee osteoarthritis using a temporary embolizing agent, imipenem/cilastatin, and a definitive embolizing agent, microspheres.;Outcome found 1: Embolization of the genicular arteries for the treatment of chronic pain and inflammatory processes related to osteoarthritis is safe using imipenem/cilastatin and Embospheres 100-300µm microspheres.

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Secondary

Measure	Time frame
Expected outcome 2: To evaluate the efficacy of genicular artery embolization with imipenem/cilastatin for the control of chronic pain, using the visual analog scale and the WOMAC and KOOS questionnaires in the treatment of knee osteoarthritis.;Outcome found 2:Embolization of the genicular arteries with imipenem/cilastatin for the treatment of chronic pain related to osteoarthritis is effective demonstrated by the reduction of VAS, reduction of WOMAC pain and increase of KOOS pain;Expected outcome 3: To evaluate the effectiveness of genicular artery embolization with microspheres for the control of chronic pain, using the visual analog scale and the WOMAC and KOOS questionnaires in the treatment of knee osteoarthritis.;Outcome found 3: Embolization of the genicular arteries with microspheres, Embospheres 100-300µm, for the treatment of chronic pain related to osteoarthritis is effective demonstrated through the reduction of VAS, reduction of WOMAC pain and increase of KOOS pain.;Expected outcome 4: To demonstrate non-inferiority between embolizing agents used in genicular artery embolization for the control of chronic pain in the treatment of knee osteoarthritis.;Outcome found 4: The two embolizing agents used were equally effective in reducing chronic knee pain related to osteoarthritis and the number and quality of adverse events. There were differences, favoring the microsphere, in the KOOS sports and KOOS quality of life questionnaires and in the volume of the embolizing agent solution injected.;Expected outcome 5: To evaluate the reduction in the use of medications to control chronic pain after genicular artery embolization in all patients and compare the results between groups.;Outcome found 5: There was a significant reduction in the use of medications to control chronic pain after the genicular artery embolization procedure, with no statistical difference between the two embolizing agents.	—

Measure

Time frame

Expected outcome 2: To evaluate the efficacy of genicular artery embolization with imipenem/cilastatin for the control of chronic pain, using the visual analog scale and the WOMAC and KOOS questionnaires in the treatment of knee osteoarthritis.;Outcome found 2:Embolization of the genicular arteries with imipenem/cilastatin for the treatment of chronic pain related to osteoarthritis is effective demonstrated by the reduction of VAS, reduction of WOMAC pain and increase of KOOS pain;Expected outcome 3: To evaluate the effectiveness of genicular artery embolization with microspheres for the control of chronic pain, using the visual analog scale and the WOMAC and KOOS questionnaires in the treatment of knee osteoarthritis.;Outcome found 3: Embolization of the genicular arteries with microspheres, Embospheres 100-300µm, for the treatment of chronic pain related to osteoarthritis is effective demonstrated through the reduction of VAS, reduction of WOMAC pain and increase of KOOS pain.;Expected outcome 4: To demonstrate non-inferiority between embolizing agents used in genicular artery embolization for the control of chronic pain in the treatment of knee osteoarthritis.;Outcome found 4: The two embolizing agents used were equally effective in reducing chronic knee pain related to osteoarthritis and the number and quality of adverse events. There were differences, favoring the microsphere, in the KOOS sports and KOOS quality of life questionnaires and in the volume of the embolizing agent solution injected.;Expected outcome 5: To evaluate the reduction in the use of medications to control chronic pain after genicular artery embolization in all patients and compare the results between groups.;Outcome found 5: There was a significant reduction in the use of medications to control chronic pain after the genicular artery embolization procedure, with no statistical difference between the two embolizing agents.

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Countries

Brazil

Contacts

Public ContactMateus Correa

Universidade de Passo Fundo

drmateus@invascrs.org+55 54 30453340

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 18, 2026