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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2025-08-01

Brief Summary

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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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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomized 1:1 into two parallel groups to receive either preoperative and postoperative cold therapy or only postoperative cold therapy.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Care providers such as nurses and physiotherapists responsible for postoperative rehabilitation and routine care were blinded to group allocation. Patients and outcome assessors were not blinded.

Study Groups

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Preoperative and Postoperative Cold Therapy

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).

Group Type EXPERIMENTAL

Preoperative and Postoperative Cold Therapy with Gel Cold Pack

Intervention Type 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.

Postoperative Cold Therapy Only

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.

Group Type ACTIVE_COMPARATOR

Postoperative Cold Therapy with Gel Cold Pack

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Traditional CryotherapY Cold Application Conventional Gel Pack Traditional Cryotherapy Cold Application Conventional Gel Pack

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No