Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome (CRYO-KNEE)

The purpose of this study is to evaluate the effectiveness of cryopressotherapy in patients undergoing total knee arthroplasty by assessing clinical improvement using the KOOS at 14 days after surgery.

Analysis of the knee Range of Motion (ROM) in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.

Analysis of PROMs such as: Oxford Knee Score (OKS), Joint Forgotten (JF), NRS score, and SF-12.

These questionnaires will be collected in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.

To evaluate whether cryopressotherapy leads to an improvement in predischarge hemoglobin (Hb) levels.

To assess whether cryopressotherapy reduces the circumference and subcutaneous fluid accumulation of the operated limb.

Study Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty\(TKA\); Osteoartrosi
• Intervention / Treatment: Device: Cryopressotherapy; Device: Ice pack

Detailed Description

Knee osteoarthritis is a degenerative condition that causes cartilage wear, leading to pain, stiffness, and difficulty moving. It mainly affects older adults, but it can also occur in younger individuals in cases of genetic predisposition or trauma. Symptoms include pain during or after physical activity, swelling, and difficulty walking.

Initial treatment is based on physiotherapy, anti-inflammatory medications, and injections, but if the disease progresses, a total knee replacement with a prosthesis may become necessary. Modern prostheses are made with advanced materials and minimally invasive surgical techniques, improving postoperative recovery.

Using ice in the first few days after surgery is crucial to reducing pain and swelling, improving functional recovery, and lowering the need for pain medications, such as opioids. Moreover, ice therapy promotes early rehabilitation and reduces hospitalization time. Cryotherapy may also help lower healthcare costs thanks to more effective pain management.

Advanced continuous cooling devices, although promising, require further studies to confirm their effectiveness.

The aim of the study is therefore to assess whether the cryopressotherapy protocol leads to an improvement in clinical outcomes in patients undergoing total knee arthroplasty (TKA), earlier mobilization, and reduced use of pain medication.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Mangiavini; Phone Number: 0283506790; Email: laura.mangiavini@unimi.it

Study Locations

• Italy
  • Italy
    • Milan, Italy, Italy, 20157
      • Recruiting
      • IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Milan 20173
      • Contact: Laura Mangiavini; Phone Number: 283506790; Email: laura.mangiavini@unimi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: will undergo a cryopressotherapy protocol using a dedicated device/machine.; Cryopressotherapy treatment (using the device) consists of applying the machine in 6-hour cycles per day, to be performed 3 hours in the morning and 3 hours in the afternoon during the 4 days after surgery.	Device: Cryopressotherapy; Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes
Active Comparator: Group B: will undergo a cryotherapy protocol using ice.; Cryotherapy (i.e., cold therapy) consists of applying local ice using an ice pack 3 times per day, with 1-hour applications alternating 15 minutes on and 15 minutes off during the first 4 days after surgery.	Device: Ice pack; Comparison between ice pack and cryopressotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 14 Days Postoperatively	The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported questionnaire consisting of 5 subscales: Pain, Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function, and Knee-Related Quality of Life. Each subscale is scored separately and transformed to a 0-100 scale, where 0 represents extreme knee problems and 100 represents no knee problems. The outcome measure is the change from preoperative baseline to 14 days postoperatively in KOOS scores	Preoperative assessment and 14 days postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of the knee Range of Motion (ROM) in the preoperative phase	Knee range of motion (ROM) measured in degrees using a goniometer. Flexion and extension will be recorded. Higher flexion values indicate better joint mobility, while lower extension deficit values indicate better functional outcome.	Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).
Analysis of PROMs (Patient-Reported Outcome Measures): Oxford Knee Score (OKS)	The Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure assessing pain and function in patients undergoing knee surgery. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating better knee function.	Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).
Analysis of PROMs (Patient-Reported Outcome Measures): Forgotten Joint Score (FJS-12)	The Forgotten Joint Score-12 (FJS-12) is a 12-item questionnaire evaluating joint awareness during daily activities. Scores range from 0 to 100, with higher scores indicating better outcome and less joint awareness.	Pre-discharge visit; 14 days postoperatively (suture removal visit).
Analysis of PROMs (Patient-Reported Outcome Measures): Numerical Rating Scale (NRS) for pain	Pain intensity measured using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain)	Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit)
Analysis of PROMs (Patient-Reported Outcome Measures): Short Form-12 Health Survey (SF-12)	The Short Form-12 (SF-12) is a validated questionnaire assessing health-related quality of life. It provides a Physical Component Summary (PCS) and a Mental Component Summary (MCS). Higher scores indicate better health status	Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit)
Improvement in hemoglobin (Hb) levels	Hemoglobin (Hb) levels measured in g/dL through standard blood testing. The change from preoperative baseline to postoperative assessment will be evaluated. Higher postoperative Hb levels indicate reduced blood loss.	Preoperative assessment and pre-discharge visit
Change in operated limb circumference	Operated limb circumference measured in centimeters (cm) using a measuring tape at standardized anatomical reference points. The change from preoperative baseline will be calculated. A reduction in circumference indicates decreased postoperative swelling.	Preoperative assessment; pre-discharge visit; 14 days postoperatively.

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
• Investigators: Principal Investigator: Laura Mangiavini, University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2025
• Primary Completion (Actual): October 13, 2025
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CRYO-KNEE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No