Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062319) titled 'Safety and Effectiveness of Cooling Therapy After TKA: Comparison of a 48-Hour Continuous Cooling Followed by Intermittent Cooling Protocol with Conventional Cooling' on July 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - Knee osteoarthritis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study was to develop a cooling device that could be used without hindering the activities of patients in the early postoperative period, and to verify its safety and efficacy by establishing a 14-day postoperative cooling protocol. In a preliminary study involving healthy adults, the safety and cooling efficacy of the new cooling device were confirmed to be satisfactory. Based on these findings, the present clinical trial was conducted to evaluate the device in patients who had undergone TKA.

Translated with DeepL.com (free version) Basic objectives2 - Safety

Intervention: Interventions/Control_1 - RCT comparing the conventional group and the new cooling method group Interventions/Control_2 - RCT comparing the conventional group and the new cooling method group

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1 Patients who undergo unilateral TKA at the Orthopaedic Surgery Department of International University of Health and Welfare Narita Hospital between 2024, after research ethics approval, and 31 August 2026. 2 Patients who are able to provide written consent to participate in the study of their own free will. 3 Patients who are aged 18 to 90 at the time of obtaining consent. 4 Hospitalised patients. Key exclusion criteria - 1 Bilateral TKA 2 Only one side of the joint 3 Revision replacement 4 Previous surgery on the same joint Target Size - 120

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 11 Month 27 Day Date of IRB - 2024 Year 11 Month 27 Day Anticipated trial start date - 2025 Year 06 Month 01 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066321

Disclaimer: Curated by HT Syndication.