CryoTKR: study protocol for a monocentric randomised controlled trial assessing cryocompression following total knee replacement

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. The purpose is to demonstrate equivalence in immediate post-operative pain between cryocompression and icepacks. A monocentric randomised controlled trial in an equivalence framework with a 1:1 allocation ratio. One surgeon from 1 centre will take part in this study. The surgeon will not be blinded to the intervention and will assess the patients at each follow-up point. The patients will not be blinded to the intervention. Patients that meet the inclusion criteria and are eligible for TKR will be given the opportunity to participate in the study. If they agree to participate, they will be randomised to cryocompression or icepacks. Secondary objectives are assessed at 1, 3, and 9 months, and include: pain on NRS, function using WOMAC, range of motion, leg oedema, wound healing, blood loss, painkiller consumption, quality of sleep, and safety. The outcomes of this study could provide important insights into whether cryocompression is equivalent compared to regular ice packs, as they 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, it is not yet clear how cryocompression affects wound healing in the short- and long-term. ClinicalTrials.gov NCT0736673. Registered on 26 January 2026.