Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cryotherapy, Game Ready.
- Who it may be relevant to
- Registry conditions: Total Knee Anthroplasty, Cryotherapy, Compression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- 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. - 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.
Primary outcome measures
- To compare post-operative pain between the intervention and the control group [Time frame: 48 hours postoperatively]
Secondary outcome measures (9)
- To compare post-operative pain during the study [Time frame: 1, 3, and 9 months]
- To compare the evolution of joint function [Time frame: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months]
- To compare the evolution of mobility [Time frame: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months]
- To compare the incidence of oedema [Time frame: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 month]
- To compare wound healing [Time frame: preoperatively, postoperatively at 48 hours and at 1, and 3 months]
- To compare blood loss [Time frame: preoperatively, and postoperatively at 24 hours, and 1 week]
- To compare pain killer consumption [Time frame: at 48 hours, and at 1, 3 and 9 months]
- To compare quality of sleep [Time frame: preoperatively, at 48 hours, and at 1, 3 and 9 months]
- To compare safety of postoperative procedures [Time frame: at 48 hours, and at 1, 3 and 9 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Clinique des Cèdres — Échirolles
Identifiers
NCT: NCT07366736 · 2025-A01217-42