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Cooling of the Knee After Total Knee Arthroplasty

NCT07416721 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee
  • Total Knee Replacement

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

Sponsors & Collaborators

  • Clinical Center of Vojvodina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-11-01
Completion
2027-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07416721 on ClinicalTrials.gov