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

Ankara City Hospital

Status: Completed

Conditions: Cryotherapy; Postoperative Pain Management; Opioid Consumption, Postoperative; Knee Osteoarthritis; Total Knee Arthroplasty

Treatments: Procedure: Postoperative Cold Therapy with Gel Cold Pack; Procedure: Preoperative and Postoperative Cold Therapy with Gel Cold Pack

Study type: Interventional

Funder types: Other

Identifiers

NCT07134283

TABED 1-24-331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

Preoperative and Postoperative Cold Therapy

Experimental group

Description:

Patients in this group received conventional cold therapy (gel pack at -17°C) both before and after surgery. Three sessions were applied preoperatively (20 minutes with 40-minute intervals), and postoperative therapy was performed identically to the control group (20 minutes on / 40 minutes off for 24 hours).

Treatment:

Procedure: Preoperative and Postoperative Cold Therapy with Gel Cold Pack

Postoperative Cold Therapy Only

Active Comparator group

Description:

Patients in this group received conventional cold therapy (gel pack at -17°C) after surgery only. Cold packs were applied to the knee region for 20 minutes with 40-minute intervals over a 24-hour postoperative period.

Treatment:

Procedure: Postoperative Cold Therapy with Gel Cold Pack