Knee Replacement Clinical Trials

Clinical trials related to Knee Replacement Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Argentina
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Contact Information
Primary
Ivan Huespe, MD
ivan.huespe@hospitalitaliano.org.ar
+543425382554
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 74
Treatments
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.
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.
Sponsors
Collaborators: Avanos Medical
Leads: Hospital Italiano de Buenos Aires

This content was sourced from clinicaltrials.gov