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NOT YET RECRUITING
NCT07416721
NA

Cooling of the Knee After Total Knee Arthroplasty

Sponsor: Clinical Center of Vojvodina

View on ClinicalTrials.gov

Summary

This study investigates whether cooling the knee after total knee replacement surgery can reduce pain and improve early recovery. After surgery, patients are randomly assigned to one of three groups: cooling with a liquid cooling bandage, cooling with an ice pack, or standard postoperative care without cooling. Cooling begins 24 hours after surgery and continues for two weeks. Pain levels, use of pain medication, blood values, knee swelling, knee movement, and length of hospital stay are recorded. The goal is to determine whether postoperative knee cooling provides additional benefits compared with standard care.

Official title: Effects of the Cooling of the Knee After Total Knee Replacement: Does It Help Compared With a Standard Protocol?

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2026-03-01

Completion Date

2027-03-01

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

DEVICE

Cool Down Liquid with Bandage ( CoolDown, CH)

The CoolDown Bandage is intended for postoperative local cooling and is capable of reducing skin and subcutaneous tissue temperature by approximately 7°C. Its proposed clinical benefits include reduction of postoperative pain, swelling, surgical-site bleeding, and opioid consumption. The bandage is designed to be applied directly over the surgical field for 2 hours per session, three times daily, allowing for prolonged and controlled cooling. This represents a significant advantage compared with conventional cryotherapy using ice packs, where the recommended application duration is typically limited to 10 minutes per session, three times daily, due to risks of cold-related tissue injury.This treatment should be started 24 hours after surgery.

OTHER

Ice package cooling system

* Application of an ice package over the operated knee * Cooling initiated 24 hours after surgery * Cooling performed for 2 weeks postoperatively * Frequency: 3 times daily * Duration: 10 minutes per session * Cooling combined with passive knee motion using a continuous passive motion (CPM) machine according to the standard rehabilitation protocol

OTHER

Standard Postoperative Protocol Without Cooling

* Standard postoperative care without cooling * Passive knee motion using a CPM machine according to the same standard rehabilitation protocol