Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
NCT Number: NCT07134283
This prospective, single-center, randomized controlled trial investigates the effects of preoperative cold therapy on early postoperative outcomes in patients undergoing unilateral primary total knee arthroplasty (TKA). A total of 208 patients were randomized into two groups: one receiving conventional cold therapy preoperatively and postoperatively, and the other receiving only routine postoperative cold therapy. Primary outcomes included postoperative pain (VAS), edema (thigh circumference), hemoglobin levels, drainage volume, opioid usage, Knee Society Scores (KSS), and presence of ecchymosis. The study demonstrated that initiating cold therapy before surgery significantly reduced postoperative drainage and opioid requirement, and delayed early edema progression. These findings suggest that the timing of cold therapy may influence recovery, highlighting a potentially beneficial approach to perioperative care in TKA.
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Notify Me55 year and older
All sexes
Interventional
Not applicable
Ankara, 06800, Turkey (Türkiye)
This prospective, single-center, randomized controlled study aims to evaluate the early postoperative effects of initiating cold therapy in the preoperative period in patients undergoing total knee arthroplasty (TKA). While cold therapy is routinely applied in the postoperative period to reduce pain, swelling, and inflammation, limited evidence exists regarding the impact of starting cold therapy before surgery. In this study, a total of 208 patients diagnosed with advanced degenerative knee osteoarthritis and scheduled for unilateral primary cemented TKA were randomly assigned to two groups: one receiving conventional gel-based cold therapy both preoperatively and postoperatively (intervention group), and one receiving only standard postoperative cold therapy (control group).
Cold therapy was applied using gel packs at -17°C for 20 minutes with 40-minute intervals. The intervention group received three preoperative sessions prior to surgery and continued postoperatively for 48 hours. The control group received only the postoperative protocol.
The primary outcomes were postoperative pain (measured using Visual Analog Scale - VAS), edema (thigh circumference), hemoglobin levels, drainage output at 24 hours, and opioid consumption during the first 48 hours. Secondary outcomes included Knee Society Scores (KSS), hospital stay duration, and presence of ecchymosis.
The results demonstrated that preoperative initiation of cold therapy significantly reduced postoperative drainage volume and opioid consumption, and showed a trend toward slower edema progression and lower pain scores in the early postoperative period. This study proposes a novel approach in perioperative management by emphasizing the importance of cold therapy timing, and provides evidence that beginning therapy preoperatively may enhance recovery outcomes after TKA.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cold therapy was applied using a conventional gel cold pack , pre-cooled at -17°C for at least 2 hours. In the intervention group, cold application was performed three times before surgery (20 minutes per session with 40-minute intervals), and continued postoperatively for 24 hours with the same frequency. This protocol aimed to reduce pain, swelling, bleeding, and improve functional outcomes after total knee arthroplasty.
Other names: Traditional CryotherapY, Cold Application, Conventional Gel Pack
Cold therapy applied only in the postoperative period, for 24 hours, using the same method as the intervention group (20-minute applications with 40-minute breaks.
Other names: Traditional Cryotherapy, Cold Application, Conventional Gel Pack
Time frame: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Pain intensity was assessed using the Visual Analog Scale (VAS) at rest at four time points: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Scale Range: 0 (no pain) - 10 (worst imaginable pain)
Directionality: Higher scores indicate worse pain
Time frame: First 24 hours after surgery
Total amount of fluid collected in the Hemovac drainage system during the first 24 hours after total knee arthroplasty (TKA). This measure is used as an indicator of postoperative bleeding and local inflammation, comparing the effect of preoperative cold therapy.
Time frame: First 48 hours after surgery
Total opioid usage calculated as oral morphine equivalent in the first 48 hours after TKA. This includes all administered analgesics converted into oral morphine equivalent doses to evaluate pain control efficacy between study groups.
Time frame: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Hemoglobin levels were recorded at four time points to evaluate perioperative blood loss: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Time frame: Preoperative and 48 Hours Postoperative
Functional outcomes were measured using the KSS scale, which includes pain, range of motion, and stability. Scores were compared preoperatively and at 48 hours postoperatively.
Each component is scored from 0 to 100, with higher scores indicating better outcomes.
Time frame: Preoperative, 24 Hours Postoperative, 48 Hours Postoperative
Thigh circumference was measured 1 cm proximal to the superior patella border with the knee in full extension, to assess postoperative swelling. Measurements were taken preoperatively, 24 hours postoperatively, and 48 hours postoperatively.
Time frame: 24 Hours Postoperative and 48 Hours Postoperative
Ecchymosis was visually evaluated and recorded at 24 hours postoperatively and 48 hours postoperatively in both groups.
Time frame: From Surgery Until Hospital Discharge(2 to 7 Days Postoperative)
The number of patients who required postoperative blood transfusion was recorded and compared between the groups. The transfusion threshold was hemoglobin <8 g/dL in hemodynamically stable patients. The outcome will be assessed throughout the hospitalization period after surgery.
Time frame: Through Hospital Discharge (Estimated 2 to 7 Days Postoperative)
The duration of hospitalization in days was recorded for each patient, from the day of surgery until discharge.
Ankara City Hospital Bilkent
Other
The Effect of Preoperatively Initiated Cold Application on Postoperative Bleeding, Pain, and Functional Status in Total Knee Arthroplasty
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