Cooling of the Knee After Total Knee Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorClinical Center of Vojvodina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• Unregulated or poorly controlled diabetes mellitus
Rheumatoid arthritis or other inflammatory arthropathies
Presence of mental disease impairing cooperation or protocol adherence
Trial design
Design model
Parallel
Treatments tested in this trial
Cool Down Liquid with Bandage ( CoolDown, CH)
DeviceThe 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.
Ice package cooling system
Other intervention* 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
Standard Postoperative Protocol Without Cooling
Other intervention* Standard postoperative care without cooling * Passive knee motion using a CPM machine according to the same standard rehabilitation protocol
Treatment groups
99 Participants
are divided into 3 treatment groupsGroup A: Ice Package Cooling SystemActive comparator 1 intervention
Group B: Standard Postoperative Protocol Without CoolingOther 1 intervention
Group C: Cool Down Liquid Cooling SystemExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From 24 hours to 14 days postoperatively (assessed at 24, 36, and 48 hours and at postoperative days 5, 7, and 14Secondary outcomes
1
Total opioid consumption
Total opioid consumption during hospitalization and up to 2 weeks postoperatively was quantified and standardized by conversion to morphine milligram equivalents (MME). MME represents a normalized measure of opioid exposure that accounts for differences in potency among various opioid agents. All administered and prescribed opioid doses were converted to their equianalgesic morphine dose using established opioid conversion tables, allowing direct comparison of cumulative opioid use across patients and treatment groupsAfter discharge, patients were instructed to prospectively record all analgesic medications consumed, including drug name, dosage, and frequency, in standardized medication diaries. Diary entries were reviewed during the 2-week postoperative follow-up visit and cross-checked with prescription records to ensure accuracy
Time frame
from 48 hours to 2 weeks postoperatively2
Changes in hemoglobin (Hgb) and erythrocyte (Er) levels
Serial measurements of hemoglobin (Hgb) and erythrocyte (Er) levels will be performed preoperatively and on postoperative days 1 and 3 to evaluate perioperative blood loss, hemodilution, and early hematologic recovery. The way how we desribe changes for this measure:Preoperative values (baseline) Represent the patient's starting hematologic status. Important for identifying preexisting anemia and estimating transfusion risk. Postoperative Day 1 (POD1) Typically shows the largest decrease in Hgb and Er. Reflects: Intraoperative blood loss Early postoperative bleeding Hemodilution due to IV fluids A sharp drop suggests significant perioperative blood loss. Postoperative Day 3 (POD3) Values often stabilize or partially recover. Reflects: Physiological compensation Mobilization of extravascular fluid Early erythropoietic response (though true RBC production takes longer) Continued decline may indicate ongoing bleeding or complications.
Time frame
Assessed on postoperative day 1 and postoperative day 33
Active knee range of motion (ROM)
Active knee range of motion (ROM), defined as the maximal voluntary knee flexion and extension, was assessed using a handheld universal goniometer at discharge and at 2 weeks postoperatively, providing an objective measure of early postoperative functional outcomes.
Time frame
Discharge day and 2 weeks postoperatively4
Knee swelling measured by circumferential knee measurements
Postoperative knee swelling was evaluated by standardized circumferential measurements taken with a flexible tape measure at predefined anatomical landmarks at 48 hours, 7 days, and 2 weeks after surgery, allowing objective assessment of periarticular edema.
Time frame
Assessed at 48 hours, 7 days, and 14 days postoperativelyLocations
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Source ClinicalTrials.gov
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