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

NCT07134283 | Completed

• 1 other identifier: TABED 1-24-331
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Total Knee Arthroplasty; Preoperative Cold Therapy; Cryotherapy; Postoperative Pain; Opioid Consumption; Knee Surgery; Drainage Output

Outcome Measures

Primary Outcomes (6)

• Visual Analog Scale (VAS) Scores for Pain

  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

  Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative

• Postoperative Drainage Volume

  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.

  First 24 hours after surgery

• Total Opioid Consumption in the First 48 Hours

  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.

  First 48 hours after surgery

• Hemoglobin Level Change

  Hemoglobin levels were recorded at four time points to evaluate perioperative blood loss: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative

  Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative

• Knee Society Score (KSS)

  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.

  Preoperative and 48 Hours Postoperative

• Thigh Circumference Measurement

  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.

  Preoperative, 24 Hours Postoperative, 48 Hours Postoperative

Secondary Outcomes (3)

• Presence of Ecchymosis

  24 Hours Postoperative and 48 Hours Postoperative

• Need for Blood Transfusion

  From Surgery Until Hospital Discharge(2 to 7 Days Postoperative)

• Length of Hospital Stay

  Through Hospital Discharge (Estimated 2 to 7 Days Postoperative)

Study Arms (2)

Preoperative and Postoperative Cold Therapy

EXPERIMENTAL

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).

Procedure: Preoperative and Postoperative Cold Therapy with Gel Cold Pack

Postoperative Cold Therapy Only

ACTIVE COMPARATOR

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.

Procedure: Postoperative Cold Therapy with Gel Cold Pack

Interventions

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.

Also known as: Traditional CryotherapY, Cold Application, Conventional Gel Pack

Preoperative and Postoperative Cold Therapy

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.

Also known as: Traditional Cryotherapy, Cold Application, Conventional Gel Pack

Postoperative Cold Therapy Only

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (4)

• Pieri L, Leggieri F, Bartoli D, Ponti M, Caparrini C, Baldini A. Preoperative knee joint hypothermia reduces inflammation and recovery time and increases range of motion after total knee arthroplasty: A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2025 Dec;33(12):4312-4323. doi: 10.1002/ksa.12756. Epub 2025 Jul 2.

  PMID: 40601965 BACKGROUND

• Chareancholvanich K, Keesukpunt W, Pornrattanamaneewong C, Narkbunnam R, Jarusriwanna A. Comparison of three cryotherapy techniques for early post-TKA pain control in terms of efficacy and patient satisfaction: a randomized controlled trial. Arthroplasty. 2025 Jan 8;7(1):5. doi: 10.1186/s42836-024-00287-7.

  PMID: 39773549 BACKGROUND

• Thienpont E. Does advanced cryotherapy reduce pain and narcotic consumption after knee arthroplasty? Clin Orthop Relat Res. 2014 Nov;472(11):3417-23. doi: 10.1007/s11999-014-3810-8. Epub 2014 Jul 25.

  PMID: 25059851 BACKGROUND

• Hawker G, Wright J, Coyte P, Paul J, Dittus R, Croxford R, Katz B, Bombardier C, Heck D, Freund D. Health-related quality of life after knee replacement. J Bone Joint Surg Am. 1998 Feb;80(2):163-73. doi: 10.2106/00004623-199802000-00003.

  PMID: 9486722 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

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

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 21, 2025
• Study Start: June 10, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 1, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)