Osteoarthritis, KneeNCT07630337
Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty
A study testing Game Ready® compressive cryotherapy device and Standard cryotherapy (ice packs) in people with Osteoarthritis, Knee and Postoperative Pain, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Postoperative Pain, Total Knee Arthroplasty
- What is being tested?
- Game Ready® compressive cryotherapy device and Standard cryotherapy (ice packs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Feb 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires, C1181
Ivan a Huespe, md, 03425382554, ivan.huespe@hospitalitaliano.org.ar
About this study
Official title: 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?
Read more
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.
- Being tested
- Game Ready® compressive cryotherapy device, Standard cryotherapy (ice packs)
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game Ready® compressive cryotherapy deviceDevice
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard cryotherapy (ice packs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 7 days after surgery
Secondary outcomes (4)
Postoperative pain intensity measured using the Visual Analog Scale (VAS)
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.
Measured: Daily during the first 7 days after surgery
Knee swelling measured by limb circumference
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.
Measured: Baseline (preoperative) and postoperative day 7
Hematoma size
Hematoma size at the surgical site will be assessed on postoperative day 7 using the Fagotti square classification method and recorded in square centimeters.
Measured: Postoperative day 7
Quality of recovery measured with the QoR-15 questionnaire
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.
Measured: Postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Avanos Medical
- Responsible party
- Principal investigator, Ignacio Garcia Mansilla, Hospital Italiano de Buenos Aires
- Investigators
- Ivan A Huespe, MD, Study chair, Hospital Italiano de Buenos AiresIgancio Garcia Mansilla, MD, Principal investigator, Hospital Italiano de Buenos AiresMatias Costa Paz, MD, Study director, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630337
- Sponsor's protocol ID
- 7283
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07630337
- Acronym / sponsor ID
- 7283
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Avanos Medical
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Compressive Cryotherapy | Experimental | Device: Game Ready® compressive cryotherapy deviceParticipants 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. |
| Standard Cryotherapy (Ice Packs) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game Ready® compressive cryotherapy deviceThe 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. | Device | Compressive Cryotherapy |
| 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. | Other | Standard Cryotherapy (Ice Packs) |
Primary outcome
Total opioid consumption (tramadol tablets)
Time frame: 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.
4 secondary outcomes
Postoperative pain intensity measured using the Visual Analog Scale (VAS)
Time frame: Daily during the first 7 days after surgery
Knee swelling measured by limb circumference
Time frame: Baseline (preoperative) and postoperative day 7
Hematoma size
Time frame: Postoperative day 7
Quality of recovery measured with the QoR-15 questionnaire
Time frame: Postoperative day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivan A Huespe, MD study chair
Hospital Italiano de Buenos Aires
Igancio Garcia Mansilla, MD principal investigator
Hospital Italiano de Buenos Aires
Matias Costa Paz, MD study director
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game Ready® compressive cryotherapy device and Standard cryotherapy (ice packs) in people with Osteoarthritis, Knee and Postoperative Pain, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Huespe, MD (+543425382554, ivan.huespe@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (tramadol tablets) (time frame: First 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.