Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement

Clinique des Cèdres138 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

138

Conditions

Total Knee Anthroplasty

Interventions

CryotherapyDEVICE

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 ReadyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

To compare wound healing

Qualitative assessment: preoperatively, postoperatively assessed at 48 hours and at 1, and 3 months

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

To compare blood loss

Blood hemoglobin levels, preoperatively, and postoperatively at 24 hours, and 1 week

Time frame: preoperatively, and postoperatively at 24 hours, and 1 week

To compare pain killer consumption

Number, type and dosage of pain killers consumed at 48 hours, and at 1, 3 and 9 months

Time frame: at 48 hours, and at 1, 3 and 9 months

To compare quality of sleep

Using Pittsburgh Sleep Quality Index (PSQI) preoperatively, at 48 hours, and at 1, 3 and 9 months. This score involves summing seven component scores, each ranging from 0 (no difficulty) to 3 (severe difficulty), to get a global score from 0 to 21, with higher scores indicating poorer sleep quality, and a score \> 5 generally suggesting significant sleep problems.

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

To compare safety of postoperative procedures

Incidence and severity of all adverse events related to the procedures