Cryopressotherapy after total knee replacement

Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome

This trial will test whether cryopressotherapy (continuous cold with compression) helps people having total knee replacement recover faster with less pain, swelling, and blood loss.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio (other)
• Locations: 1 site (Milan, Italy)
• Trial ID: NCT07456787 on ClinicalTrials.gov

What this trial studies

Adults undergoing elective primary total knee arthroplasty for osteoarthritis will receive either cryopressotherapy or standard ice packs in the immediate postoperative period, with treatments applied during hospitalization and follow-up. The primary outcome is the KOOS score measured 14 days after surgery, with additional measurements of knee range of motion, Oxford Knee Score, Joint Forgotten score, NRS pain score, SF-12, predischarge hemoglobin, and limb circumference/subcutaneous fluid. Questionnaires and physical measures are collected preoperatively, at predischarge, and at the 14-day suture-removal visit to compare short-term functional recovery, pain, swelling, and hemoglobin between groups. The trial is conducted at a single center in Milan, Italy, to determine whether continuous cooling with compression accelerates mobilization or reduces analgesic needs after TKA.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 with non-inflammatory osteoarthritis scheduled for elective primary total knee arthroplasty and a BMI between 18 and 35 who can provide informed consent.

Not a fit: Patients unlikely to receive benefit include those with BMI ≥35, active or suspected knee infection, planned revision TKA, pacemakers or mechanical implants that could be affected by device interference, or those on medications that alter muscle metabolism.

Why it matters

Potential benefit: If successful, this approach could speed early recovery, reduce pain and swelling, lower opioid use, and shorten hospital stays after total knee replacement.

How similar studies have performed: Previous studies of postoperative cryotherapy have shown mixed but often modest short-term reductions in pain and swelling, while continuous cryopressotherapy devices have produced promising but not yet definitive results.

Eligibility criteria

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

Where this trial is running

Milan, Italy

• IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Milan 20173 — Milan, Italy, Italy (RECRUITING)

Study contacts

• Principal investigator: Laura Mangiavini — University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
• Study coordinator: Laura Mangiavini

Conditions: Total Knee Arthroplasty\, Osteoartrosi