About this trial
The goal of this clinical trial is to learn if compressive cryotherapy can reduce postoperative opioid consumption in patients undergoing primary total knee arthroplasty. It will also evaluate whether compressive cryotherapy improves postoperative recovery compared with standard care using conventional ice application. The main questions it aims to answer are:
Does compressive cryotherapy reduce the total consumption of opioids during the first 7 days after total knee arthroplasty?
Does compressive cryotherapy reduce postoperative pain and improve early recovery compared with standard cryotherapy?
Researchers will compare compressive cryotherapy using the Game Ready® device with standard care using traditional ice packs to determine whether the intervention reduces opioid consumption and improves postoperative outcomes.
Participants will:
Be randomly assigned to receive compressive cryotherapy or standard cryotherapy with ice packs after surgery.
Apply the assigned treatment four times per day during the first 7 postoperative days.
Record daily pain levels using a visual analog scale (VAS) and document opioid consumption in a pain diary.
Attend a follow-up visit on postoperative day 7 for evaluation of knee swelling, hematoma size, and recovery using the QoR-15 questionnaire.
Eligibility criteria
Qualifiers
Age between 60 and 80 years
Scheduled to undergo primary total knee arthroplasty for knee osteoarthritis
Ability to understand the study procedures and provide written informed consent
Disqualifiers
Revision total knee arthroplasty
Vascular disorders affecting the lower limbs
Body mass index (BMI) greater than 35 kg/m²
Active knee infection
Trial design
Treatments tested in this trial
- Game Ready® compressive cryotherapy device
- Standard cryotherapy (ice packs)
Treatment groups
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and collaborators
Hospital Italiano de Buenos Aires
Lead sponsor
Avanos Medical
Collaborator