NCT07416721

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

January 29, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

January 29, 2026

Last Update Submit

February 13, 2026

Conditions

Osteoarthritis, KneeTotal Knee Replacement

Keywords

knee osteoarthritispostoperative coolingtotal knee replacement

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    VAS (Visual Analog Scale) is a simple and widely used tool for measuring subjective pain intensity. It consists of a straight horizontal line, usually 10 cm long, with endpoints representing: 0 = no pain 10 = worst pain imaginable The patient marks a point on the line that best corresponds to their current pain level. The distance from the "no pain" end to the patient's mark is measured in centimeters or millimeters to quantify pain intensity.

    From 24 hours to 14 days postoperatively (assessed at 24, 36, and 48 hours and at postoperative days 5, 7, and 14

Secondary Outcomes (5)

  • Total opioid consumption

    from 48 hours to 2 weeks postoperatively

  • Changes in hemoglobin (Hgb) and erythrocyte (Er) levels

    Assessed on postoperative day 1 and postoperative day 3

  • Active knee range of motion (ROM)

    Discharge day and 2 weeks postoperatively

  • Knee swelling measured by circumferential knee measurements

    Assessed at 48 hours, 7 days, and 14 days postoperatively

  • Length of hospital stay

    days from surgery to discharge

Study Arms (3)

Ice Package Cooling System

ACTIVE COMPARATOR

Application of an ice package over the operated knee during in accordance with study protocol

Other: Ice package cooling system

Standard Postoperative Protocol Without Cooling

OTHER

Standard postoperative care without cooling

Other: Standard Postoperative Protocol Without Cooling

Cool Down Liquid Cooling System

EXPERIMENTAL

Application of Cool Down liquid bandage over the operated knee

Device: Cool Down Liquid with Bandage ( CoolDown, CH)

Interventions

Cool Down Liquid with Bandage ( CoolDown, CH)DEVICE

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.

Cool Down Liquid Cooling System
Ice package cooling systemOTHER

* 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

Ice Package Cooling System
Standard Postoperative Protocol Without CoolingOTHER

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

Standard Postoperative Protocol Without Cooling

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults undergoing primary total knee arthroplasty
  • Use of a primary knee prosthesis of identical design in all patients
  • Body mass index (BMI) \< 35 kg/m²
  • Ability to understand the study protocol and comply with postoperative instructions
  • Absence of diagnosed mental disease

You may not qualify if:

  • Unregulated or poorly controlled diabetes mellitus
  • Rheumatoid arthritis or other inflammatory arthropathies
  • Presence of mental disease impairing cooperation or protocol adherence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Engelhard D, Hofer P, Annaheim S. Evaluation of the effect of cooling strategies on recovery after surgical intervention. BMJ open sport & exercise medicine. 2019 Jun 14;5(1).

    BACKGROUND

  • Krampe PT, Bendo AJ, Barros MI, Bertolini GR, Buzanello Azevedo MR. Cryotherapy in knee arthroplasty: systematic review and meta-analysis. Therapeutic hypothermia and temperature management. 2023 Jun 1;13(2):45-54.

    BACKGROUND

  • Yang L, Zhan YF, Zhai ZJ, Ruan H, Li HW. Mechanisms and parameters of cryotherapy intervention for early postoperative swelling following total knee arthroplasty: A scoping review. Journal of Experimental Orthopaedics. 2025 Jan;12(1):e70197.

    BACKGROUND

  • Wyatt PB, Nelson CT, Cyrus JW, Goldman AH, Patel NK. The role of cryotherapy after total knee arthroplasty: a systematic review. The Journal of Arthroplasty. 2023 May 1;38(5):950-6.

    BACKGROUND

  • Aggarwal A, Adie S, Harris IA, Naylor J. Cryotherapy following total knee replacement. Cochrane Database of Systematic Reviews. 2023(9).

    BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Bandages

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Oliver Dulic, MD, PhD

CONTACT

+381654404400oliver.dulic@mf.uns.ac.rs

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.Oliver Dulic, MD,PhD, Orthopedic Surgeon and Traumatologist

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 18, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All collected data

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
no limit
Access Criteria
no limit