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

NCT07630337 | Recruiting DMC FDA Device

• 1 other identifier: 7283
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Total Knee Arthroplasty; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption (tramadol tablets)

  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

Secondary Outcomes (4)

• Postoperative pain intensity measured using the Visual Analog Scale (VAS)

  Daily during the first 7 days after surgery

• Knee swelling measured by limb circumference

  Baseline (preoperative) and postoperative day 7

• Hematoma size

  Postoperative day 7

• Quality of recovery measured with the QoR-15 questionnaire

  Postoperative day 7

Study Arms (2)

Compressive Cryotherapy

EXPERIMENTAL

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.

Device: Game Ready® compressive cryotherapy device

Standard Cryotherapy (Ice Packs)

ACTIVE COMPARATOR

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.

Other: Standard cryotherapy (ice packs)

Interventions

Game Ready® compressive cryotherapy device 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.

Compressive Cryotherapy

Standard cryotherapy (ice packs) OTHER

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.

Standard Cryotherapy (Ice Packs)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• Avanos Medical: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires, C1181, Argentina

RECRUITING

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 Officials

• Ivan A Huespe, MD

  Hospital Italiano de Buenos Aires

  STUDY CHAIR

• Igancio Garcia Mansilla, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

• Matias Costa Paz, MD

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

Central Study Contacts

Ivan Huespe, MD

CONTACT

+543425382554; ivan.huespe@hospitalitaliano.org.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Due to the nature of the intervention (compressive cryotherapy device versus conventional ice application), masking of participants and care providers is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Knee Orthopedic Surgeon

Model Details: This is a randomized parallel-group clinical trial with a 1:1 allocation ratio comparing compressive cryotherapy using the Game Ready® device with standard care using conventional ice packs in patients undergoing primary total knee arthroplasty. Participants will receive the assigned intervention during the first 7 postoperative days.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

AR (1)