Actively Recruiting
Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement
Led by Clinique des Cèdres · Updated on 2026-01-26
138
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of cryocompression compared to traditional icepacks to reduce inflammation and pain after total knee replacement surgery. This trial aims to assess whether cryocompression offers any additional benefit over icepacks in managing post-operative pain and healing. Previous studies have shown mixed results, and this study addresses uncertainties about cryocompression's effects on pain, mobility, wound healing, and opioid use. Participants will be randomly assigned to receive either cryocompression or icepacks immediately after surgery while staying in the hospital for 1 to 3 days. Both groups will use their assigned method continuously for 4 hours directly following surgery to reduce inflammation. The study compares these two non-invasive devices for post-operative care. Throughout the study and follow-up periods up to 9 months, participants will undergo assessments of pain, joint function, mobility, swelling, wound healing, blood loss, pain medication use, quality of sleep, and procedure safety. Data will be collected at specific time points including 48 hours, 1 month, 3 months, and 9 months after surgery to monitor recovery and outcomes carefully.
CONDITIONS
Brief Title
Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Scheduled for primary total knee replacement surgery
- Body mass index (BMI) less than 40 kg/m2
- Signed informed consent and willing to follow study protocol
- Affiliated with a social security scheme
- Able to communicate freely in French and complete questionnaires
You will not qualify if you...
- Underwent revision total knee replacement
- Underwent bilateral total knee replacement
- Unable to comply with study protocol requirements
- Pregnant or breastfeeding
- Protected status under articles L1121-6, LL121-8, and L1122-2 of the French Public Health Code
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 to 3 days
Participants undergo total knee replacement surgery followed by immediate recovery in the 'wake-up' area. They will use either icepacks or cryocompression devices for 4 hours consecutively to reduce inflammation while staying in the hospital for 1 to 3 days.
Hospital stay for 1 to 3 days with continuous post-operative care
Duration - Up to 9 months
Participants are monitored for pain, joint function, mobility, oedema, wound healing, blood loss, pain medication use, sleep quality, and safety at multiple time points after surgery.
Visits at 48 hours, 1 week, 1 month, 3 months, and 9 months post-surgery
Trial Site Locations
Total: 1 location
1
Clinique des Cèdres
Échirolles, France, 38130
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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