NCT07366736

Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Clinique des Cèdres · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Total Knee Anthroplasty
• Cryotherapy
• Compression

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-10-27
• Primary completion: 2027-07-27
• Completion: 2027-07-27
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: France