Transcatheter arterial micro-embolization for chronic post surgical pain after total knee arthroplasty

JRCT ID: jRCTs061220039

Registered date:06/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cronic post-surgical pain after total knee arthroplasty
• Date of first enrollment: 06/07/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): transcatheter arterial micro-embolization: TAME

Outcome(s)

• Primary Outcome: Difference in change from baseline in WOMAC pain subscale at 3 months between the two groups

Secondary Outcome

The conservative therapy group (Group C) will be converted to the crossover group (Group CX) using TAME if the pain persists after 3 months and the patient has hope for TAME.
(1) TAME group vs. C group: pain VAS, WOMAC score (pain, stiffness, functional subscale, total score), and Central Sensitization Inventory (CSI) at 1, 4 weeks, 3, 6, and 12 months, difference in change from baseline in total PD score between the two groups (excluding WOMAC pain subscale at 3 months)
(2) TAME group vs. CX group: pain VAS, WOMAC score (pain, stiffness, functional subscale, total score), Central Sensitization Inventory ( CSI), and total PD score from baseline.
(3) Difference in values of pain VAS, WOMAC score, CSI, and total PD score at 1 year after TAME from baseline in each of the two groups(group TAME, group CX).
(4) Concordance rate between synovitis (US-PD) and neovascularization (contrast findings) at TAME.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria will be eligible.
(1) Patients who have undergone total knee arthroplasty (TKA) for osteoarthritis (OA) for at least one year at the time of consent.
(2) Patients with a pain VAS of 30 or higher at the time of consent.
(3) Patients whose age at the time of consent acquisition is between 50 and 90 years old.
(4) Patients with poor improvement after conservative therapy (NSAID patch, education, exercise therapy) for at least 3 months prior to obtaining consent (pain VAS 30 or higher).
<at the time of crossover transition>
(5) Patients with pain VAS of 30 or more at the time of crossover group transition

Exclude criteria

Patients who meet at least one of the following criteria will be excluded from the study. Patients who meet any one of the following criteria will not be allowed to participate in this study.
(1) Patients with active indications for surgical treatment (e.g. aseptic loosening)
(2) Patients with any of the following conditions: infection, rheumatoid arthritis, or mental illness.
(3) Patients with poor alignment
(4) Patients with actively suspected pain due to spinal lesions
(5) Patients with a high psychogenic predisposition to pain
(6) Patients with poorly controlled diabetesmellitus
(7) Patients taking antithrombotic medication which can not be suspended
(8) Patients with severely impaired renal function
(9) Patients with bronchial asthma
(10) Patients taking biguanide hypoglycemic agents which can not be suspended
(11) Patients taking valproic acid
(12) Patients with allergy to IPM/CS or contrast media
(13) Patients who are difficult to follow up in the hospital during the follow up period.
(14) Patients deemed ineligible by the physician.

Related Information

• Primary Sponsor: Sugimura Natsuki