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

NCT07456787 | Recruiting

• 1 other identifier: CRYO-KNEE
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty\(TKA\); Osteoartrosi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Analysis of the knee Range of Motion (ROM) in the preoperative phase

  Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).

• Analysis of PROMs (Patient-Reported Outcome Measures): Oxford Knee Score (OKS)

  Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).

• Analysis of PROMs (Patient-Reported Outcome Measures): Forgotten Joint Score (FJS-12)

  Pre-discharge visit; 14 days postoperatively (suture removal visit).

• Analysis of PROMs (Patient-Reported Outcome Measures): Numerical Rating Scale (NRS) for 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)

  Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit)

Study Arms (2)

Group A: will undergo a cryopressotherapy protocol using a dedicated device/machine.

EXPERIMENTAL

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

Group B: will undergo a cryotherapy protocol using ice.

ACTIVE COMPARATOR

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

Interventions

Cryopressotherapy DEVICE

Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes

Group A: will undergo a cryopressotherapy protocol using a dedicated device/machine.

Ice pack DEVICE

Comparison between ice pack and cryopressotherapy

Group B: will undergo a cryotherapy protocol using ice.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

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

Milan, Italy, 20157, Italy

RECRUITING

Study Officials

• Laura Mangiavini

  University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Mangiavini

CONTACT

0283506790; laura.mangiavini@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: March 6, 2026
• Study Start: September 29, 2025
• Primary Completion: October 13, 2025
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)