Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Game Ready® compressive cryotherapy device, Standard cryotherapy (ice packs).
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Knee, Postoperative Pain, Total Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty: A Randomized Controlled Trial
Overview
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
- 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.
Primary outcome measures
- Total opioid consumption (tramadol tablets) [Time frame: First 7 days after surgery]
Secondary outcome measures (4)
- Postoperative pain intensity measured using the Visual Analog Scale (VAS) [Time frame: Daily during the first 7 days after surgery]
- Knee swelling measured by limb circumference [Time frame: Baseline (preoperative) and postoperative day 7]
- Hematoma size [Time frame: Postoperative day 7]
- Quality of recovery measured with the QoR-15 questionnaire [Time frame: Postoperative day 7]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Argentina · 1 center
- Hospital Italiano de Buenos Aires — Buenos Aires
Identifiers
NCT: NCT07630337 · 7283