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Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty

1 juni 2026 uppdaterad av: Ignacio Garcia Mansilla, Hospital Italiano de Buenos Aires

Efficacy of Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty: A Randomized Controlled Trial

The goal of this clinical trial is to learn if compressive cryotherapy can reduce postoperative opioid consumption in patients undergoing primary total knee arthroplasty. It will also evaluate whether compressive cryotherapy improves postoperative recovery compared with standard care using conventional ice application. The main questions it aims to answer are:

Does compressive cryotherapy reduce the total consumption of opioids during the first 7 days after total knee arthroplasty?

Does compressive cryotherapy reduce postoperative pain and improve early recovery compared with standard cryotherapy?

Researchers will compare compressive cryotherapy using the Game Ready® device with standard care using traditional ice packs to determine whether the intervention reduces opioid consumption and improves postoperative outcomes.

Participants will:

Be randomly assigned to receive compressive cryotherapy or standard cryotherapy with ice packs after surgery.

Apply the assigned treatment four times per day during the first 7 postoperative days.

Record daily pain levels using a visual analog scale (VAS) and document opioid consumption in a pain diary.

Attend a follow-up visit on postoperative day 7 for evaluation of knee swelling, hematoma size, and recovery using the QoR-15 questionnaire.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

74

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Age between 60 and 80 years
  • Scheduled to undergo primary total knee arthroplasty for knee osteoarthritis
  • Ability to understand the study procedures and provide written informed consent

Exclusion Criteria:

  • Revision total knee arthroplasty
  • Vascular disorders affecting the lower limbs
  • Body mass index (BMI) greater than 35 kg/m²
  • Active knee infection
  • Severe preoperative limitations in knee mobility

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Compressive Cryotherapy
Participants assigned to this arm will receive compressive cryotherapy using the Game Ready® device after primary total knee arthroplasty. The device delivers circulating cold water combined with intermittent pneumatic compression. Cryotherapy will be applied for 20 minutes, four times per day, during the first 7 postoperative days. Compression will not be applied during the first two postoperative days and will be applied at medium pressure from postoperative day 3 to day 7. All participants will also receive the standard postoperative analgesia and rehabilitation protocol.
Enhet: Game Ready® compressive cryotherapy device
The Game Ready® system provides continuous cold water circulation combined with intermittent pneumatic compression using a circumferential wrap applied to the operated knee. The device will be used for 20 minutes per session, four times per day during the first 7 postoperative days after total knee arthroplasty.
Aktiv komparator: Standard Cryotherapy (Ice Packs)
Participants assigned to this arm will receive standard postoperative care consisting of conventional cryotherapy using ice packs applied to the operated knee as needed during the first 7 postoperative days. Participants will also be advised to elevate the operated limb to help control postoperative swelling. All participants will receive the same postoperative analgesia and rehabilitation protocol as the intervention group.
Övrig: Standard cryotherapy (ice packs)
Conventional cryotherapy consisting of ice packs applied to the operated knee after surgery according to standard postoperative care. Ice packs will be applied intermittently during the first 7 postoperative days.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total opioid consumption (tramadol tablets)
Tidsram: First 7 days after surgery
Total number of tramadol tablets (50 mg each) consumed by participants during the first 7 postoperative days after primary total knee arthroplasty. Participants will record daily tramadol consumption in a pain diary, and the total number of tablets used during the study period will be calculated.
First 7 days after surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative pain intensity measured using the Visual Analog Scale (VAS)
Tidsram: Daily during the first 7 days after surgery
Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will record daily pain scores in a pain diary during the first postoperative week.
Daily during the first 7 days after surgery
Knee swelling measured by limb circumference
Tidsram: Baseline (preoperative) and postoperative day 7
Postoperative swelling will be assessed by measuring limb circumference 10 cm proximal to the superior pole of the patella and 10 cm distal to the inferior pole of the patella. Measurements will be compared with preoperative baseline values.
Baseline (preoperative) and postoperative day 7
Hematoma size
Tidsram: Postoperative day 7
Hematoma size at the surgical site will be assessed on postoperative day 7 using the Fagotti square classification method and recorded in square centimeters.
Postoperative day 7
Quality of recovery measured with the QoR-15 questionnaire
Tidsram: Postoperative day 7
Patient-reported quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire, which evaluates physical comfort, emotional state, physical independence, psychological support, and pain. Scores range from 0 to 150, with higher scores indicating better recovery.
Postoperative day 7

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hospital Italiano de Buenos Aires

Samarbetspartners

Avanos Medical

Utredare

  • Studiestol: Ivan A Huespe, MD, Hospital Italiano de Buenos Aires
  • Huvudutredare: Igancio Garcia Mansilla, MD, Hospital Italiano de Buenos Aires
  • Studierektor: Matias Costa Paz, MD, Hospital Italiano de Buenos Aires

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2026

Primärt slutförande (Beräknad)

1 februari 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

1 juni 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 7283

Plan för individuella deltagardata (IPD)

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Studerar en amerikansk FDA-reglerad läkemedelsprodukt

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Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

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