Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique des Cèdres

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

underwent revision TKR

underwent bilateral TKR

who cannot comply with the protocol requirements based on the investigator's judgment

that are pregnant or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cryotherapy

    Device

    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.

  • Game Ready

    Device

    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 groups

138 Participants
are divided into 2 treatment groups
Group A: IcepacksActive comparator 1 intervention
Group B: CryocompressionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To compare post-operative pain between the intervention and the control group

Pain measured on numeric rating scale (NRS) at 48 hours postoperatively. 0 means no pain and 10 means severe pain.

Time frame
48 hours postoperatively

Secondary outcomes

1

To compare post-operative pain during the study

Pain measured on numeric rating scale (NRS), preoperatively, and postoperatively at 1, 3, and 9 months. 0 means no pain and 10 means severe pain.

Time frame
1, 3, and 9 months
2

To compare the evolution of joint function

Function assessed using the short version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months. It comprises five pain items (0-20), two stiffness items (0-8), and seventeen physical function items (0-68), using a 0-4 Likert scale (None to Extreme). The total score ranges from 0 (best) to 96 (worst).

Time frame
preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months
3

To compare the evolution of mobility

Range of motion, including knee flexion and extension, measured using a goniometer, preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months

Time frame
preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months
4

To compare the incidence of oedema

Ipsilateral knee circumference and comparing it to the contralateral side, preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months

Time frame
preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 month

Other outcomes

Sponsors and contacts

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