Skip to main content
OpenTrials
Completed

NCT Number: NCT07134283

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 55 years
  • Diagnosed with advanced stage primary osteoarthritis of the knee
  • Scheduled for unilateral primary total knee arthroplasty
  • Provided written informed consent

Exclusion criteria

  • Secondary osteoarthritis (e.g., post-traumatic, inflammatory arthritis)
  • History of prior surgery on the affected knee
  • Known hypersensitivity or intolerance to cold
  • Comorbidities contraindicating cold therapy (e.g., diabetes mellitus, cold urticaria, peripheral vascular disease)
  • Bleeding diathesis or on anticoagulant therapy
  • History of severe hypertension or cardiovascular disease
  • Active neurological or psychiatric disorder
  • Allergy to medications used in the study protocol
  • Refusal to participate in the study

Treatment and study plan

Preoperative and Postoperative Cold Therapy with Gel Cold Pack

Procedure

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

Postoperative Cold Therapy with Gel Cold Pack

Procedure

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

Primary outcomes

  1. Visual Analog Scale (VAS) Scores for Pain

    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

  2. Postoperative Drainage Volume

    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.

  3. Total Opioid Consumption in the First 48 Hours

    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.

  4. Hemoglobin Level Change

    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

  5. Knee Society Score (KSS)

    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.

  6. Thigh Circumference Measurement

    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.

Secondary outcomes

  1. Presence of Ecchymosis

    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.

  2. Need for Blood Transfusion

    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.

  3. Length of Hospital Stay

    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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.