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NCT Number: NCT07366736

Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement

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.

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Key information

Conditions

Total Knee Anthroplasty Compression Cryotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique des Cèdres

Échirolles, 38130, France

Location status: Recruiting

Location contact

Jean-Claude Panisset, MD

CONTACT

[email protected]

+334 56 58 10 05

Jean-Claude Panisset, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 48 hours postoperatively

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

Secondary outcomes

  1. To compare post-operative pain during the study

    Time frame: 1, 3, and 9 months

    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.

  2. To compare the evolution of joint function

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

    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).

  3. To compare the evolution of mobility

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

    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

  4. To compare the incidence of oedema

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

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

  5. To compare wound healing

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

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

  6. To compare blood loss

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

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

  7. To compare pain killer consumption

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

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

  8. To compare quality of sleep

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

    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.

  9. To compare safety of postoperative procedures

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

    Incidence and severity of all adverse events related to the procedures

Sponsors and collaborators

Lead sponsor

Clinique des Cèdres

Other

Registry information

Acronym: CryoTKR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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