Safety study of Coolif high frequency system after TKA

JRCT ID: jRCTs032230726

Registered date:21/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prolonged knee Pain after TKA
• Date of first enrollment: 21/03/2024
• Target sample size: 5
• Study type: Interventional

Intervention(s)

Initiate protocol treatment in patient who have had at least 50% pain relief with knee blocks
Protocol treatment is for single use only.
Name of study equipment: Electrosurgical unit for cautery, Coolief high-frequency system for pain management (Avanos Medical Japan Inc.)
Preparation, treatment methods and other details will follow the attached document.

Outcome(s)

• Primary Outcome: Changes in the skin around the artificial joint, presence or absence of sensory abnormalities

Secondary Outcome

(1)Change in pain VAS values from baseline to 6 months after protocol treatment (JKOM category I)
(2)Score change in total JKOM and KOOS5 and each subcategory from baseline to 6 months after protocol treatment
(3)Score change in JKOM and KOOS over time before and after the above protocol treatment (up to 24 weeks)
(4)Change in radiographs of the lower extremities before and after protocol treatment (change in perimetallic area)
(5)Percentage change in Forgotten joint score 12 before and after protocol treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

(1)Patients who are between 20 and 85 years of age at the time of consent.
(2)Patients who have undergone total knee arthroplasty for knee osteoarthritis and have not yet removed.
(3)Patients with prolonged pain in the knee joint for more than 24 weeks after TKA
(4)Patients who have had insufficient response to pain treatment for knee joint pain with oral or topical medications such as NSAIDs, acetaminophen, weak opioids, pregabalin, steroids, etc.
(5)Patients with at least 50% reduction in NRS for knee nerve blocks (superior medial, superior lateral, and inferior medial knee nerve) (6 weeks prior to protocol treatment)
(6)Patients who have given their free written consent to participate in this study.

Exclude criteria

(1)Patients with arthritis such as pyogenic arthritis, gout, pseudogout, etc.
(2)Patients with any kind of pre-existing neurological disease (diabetic peripheral neuropathy, arteriosclerosis obliterans,severe mental illness)
(3)Patients with infectious diseases
(4)Patients with blood coagulation disorder or using anticoagulants
(5)Patients who have already received treatment with the study device.
(6)Patients who use implantable cardiac pacemakers, automatic implantable cardioverter-defibrillators, etc.
(7)Patients who are unable to answer the subjective evaluation questionnaire regarding pain due to cognitive impairment.
(8)Patients whose participation in this study is deemed inappropriate by the investigators.

Related Information

• Primary Sponsor: Kaneko Haruka