Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement
Recruiting now · Not applicable
Conditions studied: Total Knee Anthroplasty, Cryotherapy, Compression
In brief
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.
Key facts
- Study ID
- NCT07366736
- Run by
- Clinique des Cèdres
- People needed
- 138
- Starts
- 2025-10-27
- Expected to finish
- 2027-07-27
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Clinique des Cèdres — Échirolles, France (enrolling)
Full record on ClinicalTrials.gov
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