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New cold therapy device could speed up knee surgery recovery

NCT ID NCT07456787

Symptom relief Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a special cold compression device (cryopressotherapy) to standard ice packs for people recovering from total knee replacement. Researchers will measure pain, mobility, swelling, and patient-reported outcomes 14 days after surgery. The goal is to see if the device leads to better recovery than ice alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cryopressotherapy device
What this could lead to
If it works, this could offer a more effective way to reduce pain and swelling after knee replacement surgery, helping patients recover faster.
What could go wrong
This is a small, early-stage trial with only 78 participants, so results may not apply to everyone. The device may not prove better than simple ice packs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Candidates for elective total knee arthroplasty surgery (indication determined solely by the Orthopedic Surgeon) * Patients aged between 18 and 80 years (inclusive) for both groups * Body Mass Index (BMI) between 18 and 35 kg/m² * Willingness and ability to provide informed consent * Patients with non-inflammatory degenerative knee joint disease, including osteoarthritis Exclusion Criteria: * Use of medications that may interfere with muscle metabolism * Bone metastases or diseases at the surgical site * Presence or suspicion of infection at the knee * Inability to provide informed consent * Obesity (BMI ≥ 35 kg/m²) * Patients requiring revision surgery of total knee arthroplasty * Patients with pacemakers and/or mechanical implants or those who may be affected by BIA interference

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoartrosi Total knee arthroplasty (TKA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Milan 20173

    RECRUITING

    Milan, Italy, 20157, Italy

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