NCT07416721

Cooling of the Knee After Total Knee Arthroplasty

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Clinical Center of Vojvodina · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Postoperative pain, swelling, blood loss, and delayed functional recovery are common challenges after total knee arthroplasty (TKA). Cryotherapy has been proposed as a simple, non-invasive adjunct therapy to reduce these postoperative problems. However, published evidence is inconsistent because of differences in cooling devices, application duration, and study methodology. This randomized controlled clinical trial aims to evaluate the clinical effectiveness of a standardized cooling protocol using a Cool Down liquid bandage compared with ice package cooling and a standard postoperative protocol without cooling in patients undergoing primary TKA. All patients receive the same implant design and standardized surgical and perioperative management. Patients are randomized into three parallel groups: Cool Down liquid bandage cooling, ice package cooling, or no cooling. Cooling is initiated 24 hours postoperatively and continues for two weeks, three times daily. Passive knee motion using a continuous passive motion (CPM) machine is applied in all groups according to the same rehabilitation protocol. The primary outcome is postoperative pain intensity measured by the Visual Analog Scale (VAS) at 48 hours after surgery. Secondary outcomes include opioid consumption expressed in morphine milligram equivalents (MME), changes in hemoglobin and erythrocyte levels, knee range of motion, knee swelling, and length of hospital stay. The study is designed to clarify whether standardized postoperative knee cooling provides measurable clinical benefits and may help define evidence-based postoperative care pathways after total knee replacement.

Conditions

• Osteoarthritis, Knee
• Total Knee Replacement

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-11-01
• Completion: 2027-03-01
• First posted: 2026-02-18
• Last updated: 2026-02-18