Effects of the Cooling of the Knee After Total Knee Replacement: Does It Help Compared With a Standard Protocol?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 99
- Primary Endpoint
- Visual Analog Scale
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• 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
Exclusion Criteria
- •• Unregulated or poorly controlled diabetes mellitus
- •Rheumatoid arthritis or other inflammatory arthropathies
- •Presence of mental disease impairing cooperation or protocol adherence
Arms & Interventions
Ice Package Cooling System
Application of an ice package over the operated knee during in accordance with study protocol
Intervention: Ice package cooling system (Other)
Standard Postoperative Protocol Without Cooling
Standard postoperative care without cooling
Intervention: Standard Postoperative Protocol Without Cooling (Other)
Cool Down Liquid Cooling System
Application of Cool Down liquid bandage over the operated knee
Intervention: Cool Down Liquid with Bandage ( CoolDown, CH) (Device)
Outcomes
Primary Outcomes
Visual Analog Scale
Time Frame: From 24 hours to 14 days postoperatively (assessed at 24, 36, and 48 hours and at postoperative days 5, 7, and 14
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.
Secondary Outcomes
- 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)
Investigators
dr Oliver Dulic MD,PhD
Ass.Prof.Oliver Dulic, MD,PhD, Orthopedic Surgeon and Traumatologist
Clinical Center of Vojvodina