NCT07366736 Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement
| NCT ID | NCT07366736 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinique des Cèdres |
| Condition | Total Knee Anthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2027-07-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 138 participants in total. It began in 2025-10-27 with a primary completion date of 2027-07-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Frequently Asked Questions
Who can join the NCT07366736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Anthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07366736 currently recruiting?
Yes, NCT07366736 is actively recruiting participants. Visit ClinicalTrials.gov or contact Clinique des Cèdres to inquire about joining.
Where is the NCT07366736 trial being conducted?
This trial is being conducted at Échirolles, France.
Who is sponsoring the NCT07366736 clinical trial?
NCT07366736 is sponsored by Clinique des Cèdres. The trial plans to enroll 138 participants.