Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Italiano de Buenos Aires
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Game Ready® compressive cryotherapy device
DeviceThe Game Ready® system provides continuous cold water circulation combined with intermittent pneumatic compression using a circumferential wrap applied to the operated knee. The device will be used for 20 minutes per session, four times per day during the first 7 postoperative days after total knee arthroplasty.
Standard cryotherapy (ice packs)
Other interventionConventional cryotherapy consisting of ice packs applied to the operated knee after surgery according to standard postoperative care. Ice packs will be applied intermittently during the first 7 postoperative days.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Compressive CryotherapyExperimental treatment 1 intervention
Group B: Standard Cryotherapy (Ice Packs)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total opioid consumption (tramadol tablets)
Total number of tramadol tablets (50 mg each) consumed by participants during the first 7 postoperative days after primary total knee arthroplasty. Participants will record daily tramadol consumption in a pain diary, and the total number of tablets used during the study period will be calculated.
Time frame
First 7 days after surgerySecondary outcomes
1
Postoperative pain intensity measured using the Visual Analog Scale (VAS)
Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will record daily pain scores in a pain diary during the first postoperative week.
Time frame
Daily during the first 7 days after surgery2
Knee swelling measured by limb circumference
Postoperative swelling will be assessed by measuring limb circumference 10 cm proximal to the superior pole of the patella and 10 cm distal to the inferior pole of the patella. Measurements will be compared with preoperative baseline values.
Time frame
Baseline (preoperative) and postoperative day 73
Hematoma size
Hematoma size at the surgical site will be assessed on postoperative day 7 using the Fagotti square classification method and recorded in square centimeters.
Time frame
Postoperative day 74
Quality of recovery measured with the QoR-15 questionnaire
Patient-reported quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire, which evaluates physical comfort, emotional state, physical independence, psychological support, and pain. Scores range from 0 to 150, with higher scores indicating better recovery.
Time frame
Postoperative day 7Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Hospital Italiano de Buenos AiresRecruitingC1181, Buenos Aires, Buenos Aires
Argentina
ArgentinaSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Italiano de Buenos Aires
Lead sponsor
Avanos Medical
Collaborator
Source ClinicalTrials.gov