Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement

Обзор

Immediately following surgery, icepacks are commonly used to decrease inflammation and reduce pain and have demonstrated to decrease post-operative opioid consumption. New cryocompression devices have been introduced as a non-invasive and non-pharmacological modality used to manage acute inflammation and pain, demonstrating benefits in the post- operative setting promoting vasoconstriction, reducing blood flow and inflammation. The addition of compression may further decrease inflammation and pain, revealed in studies on anterior cruciate ligament reconstruction, total hip replacement, and lumbar fusion. Recently, an RCT was published by Marinova et al. that compared cryocompression to icepacks following TKR in terms of pain on VAS, range of motion (ROM), knee circumference, and opioid consumption, but only found significant differences in extension ROM at day 1 and at 2 weeks. Due to the small sample size of Marinova et al. and high rates of losses to follow-up due to COVID-19, there remains doubt on the efficacy of cryocompression for TKR. Furthermore, cryocompression require additional investment in terms of cost to acquire the devices, and in time to train the hospital staff, and the devices may not be available for every patient. Finally, the authors are unsure how cryocompression affects wound healing in the short- and long-term. The hypothesis was that both cryocompression and regular icepacks would grant equivalent pain on numeric rating scale at 48 hours postoperatively.

Вмешательства

• Устройство Cryotherapy
  Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the icepacks to reduce inflammation. The patients will use icepacks for 4 hours consecutively directly following surgery.
• Устройство Game Ready
  Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the cryocompression to reduce inflammation. The patients will use cryocompression for 4 hours consecutively directly following surgery.

Первичные конечные точки

• To compare post-operative pain between the intervention and the control group [Срок оценки: 48 hours postoperatively]

Вторичные конечные точки (9)

• To compare post-operative pain during the study [Срок оценки: 1, 3, and 9 months]
• To compare the evolution of joint function [Срок оценки: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months]
• To compare the evolution of mobility [Срок оценки: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months]
• To compare the incidence of oedema [Срок оценки: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 month]
• To compare wound healing [Срок оценки: preoperatively, postoperatively at 48 hours and at 1, and 3 months]
• To compare blood loss [Срок оценки: preoperatively, and postoperatively at 24 hours, and 1 week]
• To compare pain killer consumption [Срок оценки: at 48 hours, and at 1, 3 and 9 months]
• To compare quality of sleep [Срок оценки: preoperatively, at 48 hours, and at 1, 3 and 9 months]
• To compare safety of postoperative procedures [Срок оценки: at 48 hours, and at 1, 3 and 9 months]

Критерии участия

Критерии включения

• aged ≥18 years
• scheduled for primary TKR
• BMI <40 kg/m2
• who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment
• affiliated with a social security scheme
• with an ability to answer questionnaires and to communicate freely in French.

Критерии исключения

• underwent revision TKR
• underwent bilateral TKR
• who cannot comply with the protocol requirements based on the investigator's judgment
• that are pregnant or breastfeeding
• with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code

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

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Clinique des Cèdres — Échirolles

Идентификаторы

NCT: NCT07366736 · 2025-A01217-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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