Cooling of the Knee After Total Knee Arthroplasty

Официальное название

Effects of the Cooling of the Knee After Total Knee Replacement: Does It Help Compared With a Standard Protocol?

Обзор

This study investigates whether cooling the knee after total knee replacement surgery can reduce pain and improve early recovery. After surgery, patients are randomly assigned to one of three groups: cooling with a liquid cooling bandage, cooling with an ice pack, or standard postoperative care without cooling. Cooling begins 24 hours after surgery and continues for two weeks. Pain levels, use of pain medication, blood values, knee swelling, knee movement, and length of hospital stay are recorded. The goal is to determine whether postoperative knee cooling provides additional benefits compared with standard care.

Подробное описание

Postoperative pain, swelling, blood loss, and delayed functional recovery are common challenges after total knee arthroplasty (TKA). Cryotherapy has been proposed as a simple, non-invasive adjunct therapy to reduce these postoperative problems. However, published evidence is inconsistent because of differences in cooling devices, application duration, and study methodology.

This randomized controlled clinical trial aims to evaluate the clinical effectiveness of a standardized cooling protocol using a Cool Down liquid bandage compared with ice package cooling and a standard postoperative protocol without cooling in patients undergoing primary TKA. All patients receive the same implant design and standardized surgical and perioperative management.

Patients are randomized into three parallel groups: Cool Down liquid bandage cooling, ice package cooling, or no cooling. Cooling is initiated 24 hours postoperatively and continues for two weeks, three times daily. Passive knee motion using a continuous passive motion (CPM) machine is applied in all groups according to the same rehabilitation protocol.

The primary outcome is postoperative pain intensity measured by the Visual Analog Scale (VAS) at 48 hours after surgery. Secondary outcomes include opioid consumption expressed in morphine milligram equivalents (MME), changes in hemoglobin and erythrocyte levels, knee range of motion, knee swelling, and length of hospital stay.

The study is designed to clarify whether standardized postoperative knee cooling provides measurable clinical benefits and may help define evidence-based postoperative care pathways after total knee replacement.

Вмешательства

• Устройство Cool Down Liquid with Bandage ( CoolDown, CH)
  The CoolDown Bandage is intended for postoperative local cooling and is capable of reducing skin and subcutaneous tissue temperature by approximately 7°C. Its proposed clinical benefits include reduction of postoperative pain, swelling, surgical-site bleeding, and opioid consumption. The bandage is designed to be applied directly over the surgical field for 2 hours per session, three times daily, allowing for prolonged and controlled cooling. This represents a significant advantage compared wit
• Другое Ice package cooling system
  * Application of an ice package over the operated knee * Cooling initiated 24 hours after surgery * Cooling performed for 2 weeks postoperatively * Frequency: 3 times daily * Duration: 10 minutes per session * Cooling combined with passive knee motion using a continuous passive motion (CPM) machine according to the standard rehabilitation protocol
• Другое Standard Postoperative Protocol Without Cooling
  * Standard postoperative care without cooling * Passive knee motion using a CPM machine according to the same standard rehabilitation protocol

Первичные конечные точки

• Visual Analog Scale [Срок оценки: From 24 hours to 14 days postoperatively (assessed at 24, 36, and 48 hours and at postoperative days 5, 7, and 14]

Вторичные конечные точки (5)

• Total opioid consumption [Срок оценки: from 48 hours to 2 weeks postoperatively]
• Changes in hemoglobin (Hgb) and erythrocyte (Er) levels [Срок оценки: Assessed on postoperative day 1 and postoperative day 3]
• Active knee range of motion (ROM) [Срок оценки: Discharge day and 2 weeks postoperatively]
• Knee swelling measured by circumferential knee measurements [Срок оценки: Assessed at 48 hours, 7 days, and 14 days postoperatively]
• Length of hospital stay [Срок оценки: days from surgery to discharge]

Критерии участия

Критерии включения

• • Adults undergoing primary total knee arthroplasty

• Use of a primary knee prosthesis of identical design in all patients
• Body mass index (BMI) < 35 kg/m²
• Ability to understand the study protocol and comply with postoperative instructions
• Absence of diagnosed mental disease

Критерии исключения

• • Unregulated or poorly controlled diabetes mellitus

• Rheumatoid arthritis or other inflammatory arthropathies
• Presence of mental disease impairing cooperation or protocol adherence

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Engelhard D, Hofer P, Annaheim S. Evaluation of the effect of cooling strategies on recovery after surgical intervention. BMJ Open Sport Exerc Med. 2019 Jun 14;5(1):e000527. doi: 10.1136/bmjsem-2019-000527. eCollection 2019. PMID 31275604
• Krampe PT, Bendo AJP, Barros MIG, Bertolini GRF, Buzanello Azevedo MR. Cryotherapy in Knee Arthroplasty: Systematic Review and Meta-Analysis. Ther Hypothermia Temp Manag. 2023 Jun;13(2):45-54. doi: 10.1089/ther.2022.0043. Epub 2022 Dec 5. PMID 36472555
• Yang L, Zhan YF, Zhai ZJ, Ruan H, Li HW. Mechanisms and parameters of cryotherapy intervention for early postoperative swelling following total knee arthroplasty: A scoping review. J Exp Orthop. 2025 Mar 7;12(1):e70197. doi: 10.1002/jeo2.70197. eCollection 2025 Jan. PMID 40059958
• Wyatt PB, Nelson CT, Cyrus JW, Goldman AH, Patel NK. The Role of Cryotherapy After Total Knee Arthroplasty: A Systematic Review. J Arthroplasty. 2023 May;38(5):950-956. doi: 10.1016/j.arth.2022.12.004. Epub 2022 Dec 8. PMID 36496048
• Aggarwal A, Adie S, Harris IA, Naylor J. Cryotherapy following total knee replacement. Cochrane Database Syst Rev. 2023 Sep 14;9(9):CD007911. doi: 10.1002/14651858.CD007911.pub3. PMID 37706609

Идентификаторы

NCT: NCT07416721 · CCvojvodina

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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