Cryocompression versus icepacks after total knee replacement
Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement
NA · Clinique des Cèdres · NCT07366736
This trial will test whether using a cryocompression device (Game Ready) after primary total knee replacement reduces pain, swelling, and opioid use in adult patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique des Cèdres (other) |
| Locations | 1 site (Échirolles) |
| Trial ID | NCT07366736 on ClinicalTrials.gov |
What this trial studies
This monocentric randomized controlled trial will compare postoperative cryocompression using a Game Ready device to standard icepacks in adults having primary total knee replacement. Participants who meet inclusion criteria will be randomized and receive the assigned cold therapy after surgery, with teams recording pain on a visual analogue scale, range of motion, knee circumference, and opioid consumption. The trial builds on a small RCT by Marinova et al. that found only short-term improvement in extension range of motion, so this study aims to provide more definitive data with fewer losses to follow-up. The study is conducted at Clinique des Cèdres in Échirolles and requires on-site visits and French-language communication.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for primary unilateral total knee replacement with BMI under 40, able to consent and communicate in French, and affiliated with a French social security scheme are ideal candidates.
Not a fit: Patients having revision or bilateral knee replacements, those who are pregnant or breastfeeding, with BMI ≥40, or unable to comply with study procedures or to communicate in French are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, cryocompression could reduce post-operative pain, swelling, and opioid use, helping patients recover faster with less medication.
How similar studies have performed: Previous small trials, including Marinova et al., showed limited short-term benefit (improved extension ROM) but were underpowered and had follow-up losses, so cryocompression remains promising but not conclusively proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Échirolles
- Clinique des Cèdres — Échirolles, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Total Knee Anthroplasty, Cryotherapy, Compression