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

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.

Conditions

• Osteoarthritis, Knee
• Postoperative Pain
• Total Knee Arthroplasty

Interventions

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.

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.

Sponsors & Collaborators

• Avanos Medical

  collaborator OTHER

• Hospital Italiano de Buenos Aires

  lead OTHER

Principal Investigators

• Ivan A Huespe, MD · Hospital Italiano de Buenos Aires

• Igancio Garcia Mansilla, MD · Hospital Italiano de Buenos Aires

• Matias Costa Paz, MD · Hospital Italiano de Buenos Aires

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2027-02-01

Completion

2027-06-01

FDA Device

Yes

Countries

• Argentina