Osteoarthritis, Knee, Postoperative Pain, Total Knee Arthroplasty
Conditions
Brief summary
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.
Interventions
DEVICEGame Ready® compressive cryotherapy device
The 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.
OTHERStandard cryotherapy (ice packs)
Conventional 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.
Sponsors
Hospital Italiano de Buenos Aires
Avanos Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label trial. Due to the nature of the intervention (compressive cryotherapy device versus conventional ice application), masking of participants and care providers is not feasible.
Intervention model description
This is a randomized parallel-group clinical trial with a 1:1 allocation ratio comparing compressive cryotherapy using the Game Ready® device with standard care using conventional ice packs in patients undergoing primary total knee arthroplasty. Participants will receive the assigned intervention during the first 7 postoperative days.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Revision total knee arthroplasty * Vascular disorders affecting the lower limbs * Body mass index (BMI) greater than 35 kg/m² * Active knee infection * Severe preoperative limitations in knee mobility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption (tramadol tablets) | First 7 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity measured using the Visual Analog Scale (VAS) | Daily during the first 7 days after surgery | 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. |
| Knee swelling measured by limb circumference | Baseline (preoperative) and postoperative day 7 | 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. |
| Hematoma size | Postoperative day 7 | Hematoma size at the surgical site will be assessed on postoperative day 7 using the Fagotti square classification method and recorded in square centimeters. |
| Quality of recovery measured with the QoR-15 questionnaire | Postoperative day 7 | 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. |
Countries
Argentina
Contacts
CONTACTIvan Huespe, MD
STUDY_CHAIRIvan A Huespe, MD
Hospital Italiano de Buenos Aires
PRINCIPAL_INVESTIGATORIgancio Garcia Mansilla, MD
Hospital Italiano de Buenos Aires
STUDY_DIRECTORMatias Costa Paz, MD
Hospital Italiano de Buenos Aires
Outcome results
None listed