Total Knee Arthroplasty\(TKA\)CRYO-KNEENCT07456787
Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome
A study testing Cryopressotherapy and Ice pack in people with Total Knee Arthroplasty\(TKA\) and Osteoartrosi, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty\(TKA\), Osteoartrosi
- What is being tested?
- Cryopressotherapy and Ice pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 29 Sep 2025to Feb 2028
- Phase
- Interventional
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Milan 20173
Milan, Italy, 20157
Laura Mangiavini, 283506790, laura.mangiavini@unimi.it
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Total Knee Arthroplasty\(TKA\), Osteoartrosi
- Being tested
- Cryopressotherapy, Ice pack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryopressotherapyDevice
Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes
Ice packDevice
Comparison between ice pack and cryopressotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Ice pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative assessment and 14 days postoperatively.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: Preoperative assessment; pre-discharge visit; 14 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start29 Sep 2025
- Primary completion13 Oct 2025
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty\(TKA\)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Mangiavini, Principal investigator, University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456787
- Sponsor's protocol ID
- CRYO-KNEE
- Acronym
- CRYO-KNEE
- Status last verified
- Mar 2026
- First submitted
- 8 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No