Effect of Preoperative Cold Therapy on Early Postoperative Outcomes in Total Knee Arthroplasty
Key facts
- Who runs it
- Ankara City Hospital Bilkent
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 208 people enrolled
- Started
- 10 Jun 2024
- Ended
- 1 Aug 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Preoperative and Postoperative Cold Therapy with Gel Cold Pack
- Postoperative Cold Therapy with Gel Cold Pack
- Record updated
- 21 August 2025
Who can take part
- Age
- 55 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Age ≥ 55 years
- Diagnosed with advanced stage primary osteoarthritis of the knee
- Scheduled for unilateral primary total knee arthroplasty
- Provided written informed consent
Who cannot take part
- 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
- Secondary osteoarthritis (e.g., post-traumatic, inflammatory arthritis)
- Refusal to participate in the study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Preoperative and Postoperative Cold TherapyTreatment being tested
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: Preoperative and Postoperative Cold Therapy with Gel Cold Pack
- Postoperative Cold Therapy OnlyExisting treatment, for comparison
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: Postoperative Cold Therapy with Gel Cold Pack
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of Preoperatively Initiated Cold Application on Postoperative Bleeding, Pain, and Functional Status in Total Knee Arthroplasty
- Record updated
- 21 August 2025