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NCT Number: NCT07630337

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Rheumatic Diseases Signs and Symptoms Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

Buenos Aires, C1181, Argentina

Location status: Recruiting

Location contact

Ivan a Huespe, md

CONTACT

[email protected]

03425382554

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Game Ready® compressive cryotherapy device

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.

Standard cryotherapy (ice packs)

Other

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.

Primary outcomes

  1. Total opioid consumption (tramadol tablets)

    Time frame: 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 outcomes

  1. Postoperative pain intensity measured using the Visual Analog Scale (VAS)

    Time frame: 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.

  2. Knee swelling measured by limb circumference

    Time frame: 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.

  3. Hematoma size

    Time frame: 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.

  4. Quality of recovery measured with the QoR-15 questionnaire

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ivan Huespe, MD

CONTACT

[email protected]

+543425382554

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Collaborators

  • Avanos Medical

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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