An interventional study of Cool Down Liquid with Bandage ( CoolDown, CH) and Ice package cooling system in Osteoarthritis, Knee and Total Knee Replacement, sponsored by Clinical Center of Vojvodina. Completed at 1 site in Serbia. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Clinical Center of Vojvodina · Not applicable, Interventional, and Treatment
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.
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 99 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Clinical Center of Vojvodina is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Adults undergoing primary total knee arthroplasty
Exclusion Criteria:
Unregulated or poorly controlled diabetes mellitus
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Application of an ice package over the operated knee during in accordance with study protocol
Other: Ice package cooling system
Standard postoperative care without cooling
Other: Standard Postoperative Protocol Without Cooling
Application of Cool Down liquid bandage over the operated knee
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.
* 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 care without cooling * Passive knee motion using a CPM machine according to the same standard rehabilitation protocol
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 14
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 postoperatively
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 3
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 postoperatively
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 postoperatively
Length of hospital stay
Hospital length of stay will be calculated as the total number of days from the day of surgery to the day of discharge and will be used as an indicator of early postoperative recovery, complication burden, and efficiency of perioperative care.
Time frame: days from surgery to discharge
Plan to share: Yes — All collected data
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: no limit
Access criteria: no limit
Ran from Mar 2026 to primary completion in Oct 2026, 7 months.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 7 months is below that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: primary completion Nov 2026 → Oct 2026 and completion Mar 2027 → Oct 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Clinical Center of Vojvodina