Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty

Efficacy of Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty: A Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Osteoarthritis, Knee; Total Knee Arthroplasty
• Intervention / Treatment: Device: Game Ready® compressive cryotherapy device; Other: Standard cryotherapy (ice packs)

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Huespe, MD; Phone Number: +543425382554; Email: ivan.huespe@hospitalitaliano.org.ar

Study Locations

• Argentina
  • Buenos Aires
    • Buenos Aires, Buenos Aires, Argentina, C1181
      • Recruiting
      • Hospital Italiano de Buenos Aires
      • Contact: Ivan a Huespe, md; Phone Number: 03425382554; Email: ivan.huespe@hospitalitaliano.org.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Compressive Cryotherapy; Participants assigned to this arm will receive compressive cryotherapy using the Game Ready® device after primary total knee arthroplasty. The device delivers circulating cold water combined with intermittent pneumatic compression. Cryotherapy will be applied for 20 minutes, four times per day, during the first 7 postoperative days. Compression will not be applied during the first two postoperative days and will be applied at medium pressure from postoperative day 3 to day 7. All participants will also receive the standard postoperative analgesia and rehabilitation protocol.	Device: Game 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.
Active Comparator: Standard Cryotherapy (Ice Packs); Participants assigned to this arm will receive standard postoperative care consisting of conventional cryotherapy using ice packs applied to the operated knee as needed during the first 7 postoperative days. Participants will also be advised to elevate the operated limb to help control postoperative swelling. All participants will receive the same postoperative analgesia and rehabilitation protocol as the intervention group.	Other: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Daily during the first 7 days after surgery
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.	Baseline (preoperative) and postoperative day 7
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.	Postoperative day 7
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.	Postoperative day 7

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Collaborators: Avanos Medical
• Investigators: Study Chair: Ivan A Huespe, MD, Hospital Italiano de Buenos Aires; Principal Investigator: Igancio Garcia Mansilla, MD, Hospital Italiano de Buenos Aires; Study Director: Matias Costa Paz, MD, Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Osteoarthritis, Knee
• Other Study ID Numbers: 7283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes