Total Knee AnthroplastyCryoTKRNCT07366736
Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement
A study testing Cryotherapy and Game Ready in people with Total Knee Anthroplasty and Cryotherapy, run by Clinique des Cèdres at 1 site in France.
Trial summary
Immediately following surgery, icepacks are commonly used to decrease inflammation and reduce pain and have demonstrated to decrease post-operative opioid consumption. New cryocompression devices have been introduced as a non-invasive and non-pharmacological modality used to manage acute inflammation and pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Anthroplasty, Cryotherapy, Compression
- What is being tested?
- Cryotherapy and Game Ready
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2025to 27 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥18 years
- scheduled for primary TKR
- BMI <40 kg/m2
- who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment
- affiliated with a social security scheme
- with an ability to answer questionnaires and to communicate freely in French.
Who cannot join
- underwent revision TKR
- underwent bilateral TKR
- who cannot comply with the protocol requirements based on the investigator's judgment
- that are pregnant or breastfeeding
- with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique des Cèdres
Échirolles, 38130
Jean-Claude Panisset, MD, +334 56 58 10 05, administration@cliniquedescedres.com
Jean-Claude Panisset, MD
About this study
Immediately following surgery, icepacks are commonly used to decrease inflammation and reduce pain and have demonstrated to decrease post-operative opioid consumption. New cryocompression devices have been introduced as a non-invasive and non-pharmacological modality used to manage acute inflammation and pain, demonstrating benefits in the post- operative setting promoting vasoconstriction, reducing blood flow and inflammation. The addition of compression may further decrease inflammation and pain, revealed in studies on anterior cruciate ligament reconstruction, total hip replacement, and lumbar fusion.
Recently, an RCT was published by Marinova et al. that compared cryocompression to icepacks following TKR in terms of pain on VAS, range of motion (ROM), knee circumference, and opioid consumption, but only found significant differences in extension ROM at day 1 and at 2 weeks. Due to the small sample size of Marinova et al. and high rates of losses to follow-up due to COVID-19, there remains doubt on the efficacy of cryocompression for TKR. Furthermore, cryocompression require additional investment in terms of cost to acquire the devices, and in time to train the hospital staff, and the devices may not be available for every patient. Finally, the authors are unsure how cryocompression affects wound healing in the short- and long-term.
The hypothesis was that both cryocompression and regular icepacks would grant equivalent pain on numeric rating scale at 48 hours postoperatively.
- Conditions
- Total Knee Anthroplasty, Cryotherapy, Compression
- Being tested
- Cryotherapy, Game Ready
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the icepacks to reduce inflammation. The patients will use icepacks for 4 hours consecutively directly following surgery.
Game ReadyDevice
Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the cryocompression to reduce inflammation. The patients will use cryocompression for 4 hours consecutively directly following surgery.
| Study group | Role | What they receive |
|---|---|---|
| Icepacks | Active comparator | Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the icepacks to reduce inflammation. The patients will use icepacks for 4 hours consecutively directly following surgery. Receives: Device: Cryotherapy |
| Cryocompression | Experimental | Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the cryocompression to reduce inflammation. The patients will use cryocompression for 4 hours consecutively directly following surgery. Receives: Device: Game Ready |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare post-operative pain between the intervention and the control group
Pain measured on numeric rating scale (NRS) at 48 hours postoperatively. 0 means no pain and 10 means severe pain.
Measured: 48 hours postoperatively
Secondary outcomes (9)
To compare post-operative pain during the study
Pain measured on numeric rating scale (NRS), preoperatively, and postoperatively at 1, 3, and 9 months. 0 means no pain and 10 means severe pain.
Measured: 1, 3, and 9 months
To compare the evolution of joint function
Function assessed using the short version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months. It comprises five pain items (0-20), two stiffness items (0-8), and seventeen physical function items (0-68), using a 0-4 Likert scale (None to Extreme). The total score ranges from 0 (best) to 96 (worst).
Measured: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months
To compare the evolution of mobility
Range of motion, including knee flexion and extension, measured using a goniometer, preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months
Measured: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months
To compare the incidence of oedema
Ipsilateral knee circumference and comparing it to the contralateral side, preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months
Measured: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 month
To compare wound healing
Qualitative assessment: preoperatively, postoperatively assessed at 48 hours and at 1, and 3 months
Measured: preoperatively, postoperatively at 48 hours and at 1, and 3 months
To compare blood loss
Blood hemoglobin levels, preoperatively, and postoperatively at 24 hours, and 1 week
Measured: preoperatively, and postoperatively at 24 hours, and 1 week
To compare pain killer consumption
Number, type and dosage of pain killers consumed at 48 hours, and at 1, 3 and 9 months
Measured: at 48 hours, and at 1, 3 and 9 months
To compare quality of sleep
Using Pittsburgh Sleep Quality Index (PSQI) preoperatively, at 48 hours, and at 1, 3 and 9 months. This score involves summing seven component scores, each ranging from 0 (no difficulty) to 3 (severe difficulty), to get a global score from 0 to 21, with higher scores indicating poorer sleep quality, and a score > 5 generally suggesting significant sleep problems.
Measured: preoperatively, at 48 hours, and at 1, 3 and 9 months
To compare safety of postoperative procedures
Incidence and severity of all adverse events related to the procedures
Measured: at 48 hours, and at 1, 3 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start27 Oct 2025
- Primary completion27 Jul 2027 (estimated)
- Study completion27 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee AnthroplastyStudies 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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique des Cèdres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366736
- Sponsor's protocol ID
- 2025-A01217-42
- Acronym
- CryoTKR
- Status last verified
- Jan 2026
- First submitted
- 19 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement
- ClinicalTrials.gov ID
- NCT07366736
- Acronym / sponsor ID
- CryoTKR / 2025-A01217-42
- Conditions
- Total Knee Anthroplasty, Cryotherapy, Compression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Clinique des CèdresUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 27 Jul 2027 (estimated)
- Study completion
- 27 Jul 2027 (estimated)
- First posted
- 26 Jan 2026 (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.
Immediately following surgery, icepacks are commonly used to decrease inflammation and reduce pain and have demonstrated to decrease post-operative opioid consumption. New cryocompression devices have been introduced as a non-invasive and non-pharmacological modality used to manage acute inflammation and pain, demonstrating benefits in the post- operative setting promoting vasoconstriction, reducing blood flow and inflammation. The addition of compression may further decrease inflammation and pain, revealed in studies on anterior cruciate ligament reconstruction, total hip replacement, and lumbar fusion.
Recently, an RCT was published by Marinova et al. that compared cryocompression to icepacks following TKR in terms of pain on VAS, range of motion (ROM), knee circumference, and opioid consumption, but only found significant differences in extension ROM at day 1 and at 2 weeks. Due to the small sample size of Marinova et al. and high rates of losses to follow-up due to COVID-19, there remains doubt on the efficacy of cryocompression for TKR. Furthermore, cryocompression require additional investment in terms of cost to acquire the devices, and in time to train the hospital staff, and the devices may not be available for every patient. Finally, the authors are unsure how cryocompression affects wound healing in the short- and long-term.
The hypothesis was that both cryocompression and regular icepacks would grant equivalent pain on numeric rating scale at 48 hours postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icepacks | Active comparator | Device: CryotherapyDirectly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the icepacks to reduce inflammation. The patients will use icepacks for 4 hours consecutively directly following surgery. |
| Cryocompression | Experimental | Device: Game ReadyDirectly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the cryocompression to reduce inflammation. The patients will use cryocompression for 4 hours consecutively directly following surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged ≥18 years
- scheduled for primary TKR
- BMI <40 kg/m2
- who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment
- affiliated with a social security scheme
Key exclusion criteria (5 listed)
- underwent revision TKR
- underwent bilateral TKR
- who cannot comply with the protocol requirements based on the investigator's judgment
- that are pregnant or breastfeeding
- with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
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 |
|---|---|---|
| CryotherapyDirectly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the icepacks to reduce inflammation. The patients will use icepacks for 4 hours consecutively directly following surgery. | Device | Icepacks |
| Game ReadyDirectly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the cryocompression to reduce inflammation. The patients will use cryocompression for 4 hours consecutively directly following surgery. | Device | Cryocompression |
Primary outcome
To compare post-operative pain between the intervention and the control group
Time frame: 48 hours postoperatively
Pain measured on numeric rating scale (NRS) at 48 hours postoperatively. 0 means no pain and 10 means severe pain.
9 secondary outcomes
To compare post-operative pain during the study
Time frame: 1, 3, and 9 months
To compare the evolution of joint function
Time frame: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months
To compare the evolution of mobility
Time frame: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months
To compare the incidence of oedema
Time frame: preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 month
To compare wound healing
Time frame: preoperatively, postoperatively at 48 hours and at 1, and 3 months
To compare blood loss
Time frame: preoperatively, and postoperatively at 24 hours, and 1 week
To compare pain killer consumption
Time frame: at 48 hours, and at 1, 3 and 9 months
To compare quality of sleep
Time frame: preoperatively, at 48 hours, and at 1, 3 and 9 months
To compare safety of postoperative procedures
Time frame: at 48 hours, and at 1, 3 and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and Game Ready in people with Total Knee Anthroplasty and Cryotherapy, run by Clinique des Cèdres at 1 site in France.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare post-operative pain between the intervention and the control group (time frame: 48 hours postoperatively). 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 26 Jan 2026.