Cryotherapy EffectNCT05395273
Cryocompression After Total Knee Arthroplasty
A study testing Game Ready cryocompression in people with Cryotherapy Effect, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
Trial summary
The overall aim of this study is to evaluate the effectiveness of a cryocompression device after total knee arthroplasty (TKA) compared to standard therapy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- Game Ready cryocompression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 May 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Diagnosed Arthritis of the Knee
- Planned implantation of a primary total knee arthroplasty by the Regionalspital Surselva AG
Who cannot join
- Decompensated hypertension in the affected area
- Acute inflammatory phlebitis in the affected area
- Patients with acute paroxysmal cold hemoglobinuria, or cryoglobulinemia
- Significant vascular disruption in the affected area
- History of pulmonary embolism or risk factors for deep vein thrombosis or pulmonary embolism in the affected area
- No increased venous or lymphatic return in the affected leg is desired due to e.g. carcinoma
Show all 9Show fewer
- Raynaud's disease
- Hypersensitivity to cold
- Fear of cold/compression
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Fachhochschule Südschweiz
Landquart, Kanton Graubünden, 7302
About this study
Official title: A Randomized Controlled Trial to Evaluate the Effectiveness of Cryocompression After Total Knee Arthroplasty (TKA)
The overall aim of this study is to evaluate the effectiveness of a cryocompression device after total knee arthroplasty (TKA) compared to standard therapy.
Read the detailed description
The aim of this study is to investigate the effect of cryocompression after total knee arthroplasty (TKA) compared to a control group without cryocompression. The effect on the following parameters will be evaluated: knee and osteoarthritis outcome score (KOOS), patient satisfaction, knee girth, skin temperature, knee range of motion, morphine consumption, pain perception, the length of stay, the 10-metre walk test and the timed-up-and-go.
- Conditions
- Cryotherapy Effect
- Being tested
- Game Ready cryocompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game Ready cryocompressionDevice
Cryotherapy on the coldest tolerable level and intermittend compression on the knee
| Study group | Role | What they receive |
|---|---|---|
| Cryocompression + standard therapy | Experimental | Participants received daily crycompression by the patient to their comfort level beside the standard therapy. Receives: Device: Game Ready cryocompression |
| Standard therapy | No intervention | The standard therapy include the common physical therapy interventions, which are normally used in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline (preoperatively) Knee and Osteoarthritis Outcome Score (KOOS) at postoperatively (4th day) and 6 weeks after surgery
A knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems
Measured: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Change from Baseline (preoperatively) Range of motion at postoperatively (4th day) and 6 weeks after surgery
Range of motion of the knee
Measured: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Change from Baseline (preoperatively) Girth at postoperatively (4th day) and 6 weeks after surgery
Knee girth
Measured: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Change from Baseline (preoperatively) Timed up and Go at postoperatively (4th day) and 6 weeks after surgery
A general physical performance test used to assess mobility, balance and locomotor performance
Measured: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Change from Baseline (preoperatively) Skin temperature at postoperatively (4th day) and 6 weeks after surgery
Skin temperature of the knee
Measured: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Change from Baseline (preoperatively) Visual analogue scale at postoperatively (4th day) and 6 weeks after surgery
To measure the intensity of pain
Measured: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Change from Baseline (preoperatively) 10 Metre Walk Test at postoperatively (4th day) and 6 weeks after surgery
To assess walking speed in meters per second over 10 metres
Measured: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Change from Baseline (first day postperatively) Patient satisfaction at each day of hospitalisation
To measure the patient satisfaction of the cryocompression therapy from 0 to 10
Measured: each day of hospitalisation
Consumption of morphine
Consumption of morphine in number of pills
Measured: 6 weeks after surgery
Length of stay
Length of stay in the hospital in days
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start10 May 2022
- Primary completion28 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences and Arts of Southern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Clijsen, PhD, Principal investigator, University of Applied Sciences and Arts of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395273
- Sponsor's protocol ID
- 2022-D0056
- Status last verified
- Aug 2025
- First submitted
- 18 May 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effectiveness of Cryocompression After Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT05395273
- Acronym / sponsor ID
- 2022-D0056
- Conditions
- Cryotherapy Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Applied Sciences and Arts of Southern SwitzerlandUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this study is to evaluate the effectiveness of a cryocompression device after total knee arthroplasty (TKA) compared to standard therapy.
Detailed description
The aim of this study is to investigate the effect of cryocompression after total knee arthroplasty (TKA) compared to a control group without cryocompression. The effect on the following parameters will be evaluated: knee and osteoarthritis outcome score (KOOS), patient satisfaction, knee girth, skin temperature, knee range of motion, morphine consumption, pain perception, the length of stay, the 10-metre walk test and the timed-up-and-go.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryocompression + standard therapy | Experimental | Device: Game Ready cryocompressionParticipants received daily crycompression by the patient to their comfort level beside the standard therapy. |
| Standard therapy | No intervention | –The standard therapy include the common physical therapy interventions, which are normally used in the hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Diagnosed Arthritis of the Knee
- Planned implantation of a primary total knee arthroplasty by the Regionalspital Surselva AG
Key exclusion criteria (9 listed)
- Decompensated hypertension in the affected area
- Acute inflammatory phlebitis in the affected area
- Patients with acute paroxysmal cold hemoglobinuria, or cryoglobulinemia
- Significant vascular disruption in the affected area
- History of pulmonary embolism or risk factors for deep vein thrombosis or pulmonary embolism in the affected area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game Ready cryocompressionCryotherapy on the coldest tolerable level and intermittend compression on the knee | Device | Cryocompression + standard therapy |
Primary outcome
Change from Baseline (preoperatively) Knee and Osteoarthritis Outcome Score (KOOS) at postoperatively (4th day) and 6 weeks after surgery
Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
A knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems
Change from Baseline (preoperatively) Range of motion at postoperatively (4th day) and 6 weeks after surgery
Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Range of motion of the knee
Change from Baseline (preoperatively) Girth at postoperatively (4th day) and 6 weeks after surgery
Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Knee girth
Change from Baseline (preoperatively) Timed up and Go at postoperatively (4th day) and 6 weeks after surgery
Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
A general physical performance test used to assess mobility, balance and locomotor performance
Change from Baseline (preoperatively) Skin temperature at postoperatively (4th day) and 6 weeks after surgery
Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Skin temperature of the knee
Change from Baseline (preoperatively) Visual analogue scale at postoperatively (4th day) and 6 weeks after surgery
Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
To measure the intensity of pain
Change from Baseline (preoperatively) 10 Metre Walk Test at postoperatively (4th day) and 6 weeks after surgery
Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
To assess walking speed in meters per second over 10 metres
Change from Baseline (first day postperatively) Patient satisfaction at each day of hospitalisation
Time frame: each day of hospitalisation
To measure the patient satisfaction of the cryocompression therapy from 0 to 10
Consumption of morphine
Time frame: 6 weeks after surgery
Consumption of morphine in number of pills
Length of stay
Time frame: 6 weeks after surgery
Length of stay in the hospital in days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Clijsen, PhD principal investigator
University of Applied Sciences and Arts of Southern Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game Ready cryocompression in people with Cryotherapy Effect, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline (preoperatively) Knee and Osteoarthritis Outcome Score (KOOS) at postoperatively (4th day) and 6 weeks after surgery (time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.