NCT07630337 Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty
| NCT ID | NCT07630337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Italiano de Buenos Aires |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2026-02-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ivan A Huespe, MD
STUDY CHAIR
Hospital Italiano de Buenos Aires
Frequently Asked Questions
Who can join the NCT07630337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07630337 currently recruiting?
Yes, NCT07630337 is actively recruiting participants. Contact the research team at ivan.huespe@hospitalitaliano.org.ar for enrollment information.
Where is the NCT07630337 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina.
Who is sponsoring the NCT07630337 clinical trial?
NCT07630337 is sponsored by Hospital Italiano de Buenos Aires. The principal investigator is Ivan A Huespe, MD at Hospital Italiano de Buenos Aires. The trial plans to enroll 74 participants.