Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement (CryoTKR)

Clinique des Cèdres

Status: Enrolling

Conditions: Cryotherapy; Total Knee Anthroplasty; Compression

Treatments: Device: Cryotherapy; Device: Game Ready

Study type: Interventional

Funder types: Other

Identifiers

NCT07366736

2025-A01217-42

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Icepacks

Active Comparator group

Description:

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.

Treatment:

Device: Cryotherapy

Cryocompression

Experimental group

Description:

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.

Treatment:

Device: Game Ready