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

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 Overview

• Status: Recruiting
• Conditions: Cryotherapy; Compression; Total Knee Anthroplasty
• Intervention / Treatment: Device: Cryotherapy; Device: Game Ready

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Échirolles, France, 38130
    • Recruiting
    • Clinique des Cèdres
    • Contact: Jean-Claude Panisset, MD; Phone Number: +334 56 58 10 05; Email: administration@cliniquedescedres.com
    • Principal Investigator: Jean-Claude Panisset, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Icepacks; 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: 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.
Experimental: Cryocompression; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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	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	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	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	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	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.	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	at 48 hours, and at 1, 3 and 9 months

Collaborators and Investigators

• Sponsor: Clinique des Cèdres

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2025
• Primary Completion (Estimated): July 27, 2027
• Study Completion (Estimated): July 27, 2027

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Cryotherapy
• Other Study ID Numbers: 2025-A01217-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No