NCT07134283

Effect of Preoperative Cold Therapy on Early Postoperative Outcomes in Total Knee Arthroplasty

The Effect of Preoperatively Initiated Cold Application on Postoperative Bleeding, Pain, and Functional Status in Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Knee Osteoarthritis
• Total Knee Arthroplasty
• Cryotherapy
• Postoperative Pain Management
• Opioid Consumption, Postoperative

Interventions

Type	Name	Description
PROCEDURE	Preoperative and Postoperative Cold Therapy with Gel Cold Pack	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.
PROCEDURE	Postoperative Cold Therapy with Gel Cold 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.

Timeline

• Start date: 2024-06-10
• Primary completion: 2025-07-30
• Completion: 2025-08-01
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

1 site across 1 country: Turkey (Türkiye)