Knee InjuriesPhase 4CryogenouNCT05059535
Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery
A Phase 4 study testing standard pain relievers in people with Knee Injuries, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- standard pain relievers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2022to 10 Mar 2025
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 80 years;
- Patient to undergo prosthetic knee surgery;
- Patient in good health (ASA score 1 to 3);
- Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.
Who cannot join
- Known intolerance to any of the products administered during surgery or cryoneurolysis;
- Patient with an electric implant;
- Patient with a contraindication to cryoanalgesia (coagulation disorders, infections, nerve damage);
- Drug addict patient;
- Intervention on septic bone;
- Chronic renal failure (creatinine clearance <30 mL / min);
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- History of cryoglobulinemia, cold urticaria or Raynaud's syndrome;
- Pregnant or breastfeeding woman;
- Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient not beneficiary of a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryoneurolysis of the Saphenous Nerve or Geniculate Nerves: Impact on Postoperative Pain and Rehabilitation in Prosthetic Knee Surgery
Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.
- Conditions
- Knee Injuries
- Being tested
- standard pain relievers
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard pain relieversDrug
Also called Standard pain relievers in accordance with the current practice
Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice
| Study group | Role | What they receive |
|---|---|---|
| cryoneurolysis of the saphenous nerve | Experimental | A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty Receives: Drug: standard pain relievers |
| cryoneurolysis of geniculate nerves | Experimental | A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty Receives: Drug: standard pain relievers |
| control | Placebo comparator | No cryoneurolysis will be performed before the knee arthroplasty Receives: Drug: standard pain relievers |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 ° flexion pain 2 days after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Measured: 2 days
Secondary outcomes (9)
90 ° flexion pain 1 day after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Measured: 1 day
90 ° flexion pain 7 days after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Measured: 7 days
90 ° flexion pain 30 days after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Measured: 30 days
90 ° flexion pain 90 days after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Measured: 90 days
pain at rest at Day 1
Knee pain after intervention with a visual analogic scale of 100 mm
Measured: 1 day
pain at rest at Day 2
Knee pain after intervention with a visual analogic scale of 100 mm
Measured: 2 days
pain at rest at Day 7
Knee pain after intervention with a visual analogic scale of 100 mm
Measured: 7 days
pain at rest at Day 30
Knee pain after intervention with a visual analogic scale of 100 mm
Measured: 30 days
pain at rest at Day 90
Knee pain after intervention with a visual analogic scale of 100 mm
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start12 Jan 2022
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Why it stopped: the recruitment rate is far too low despite an 18-month extension of the inclusion period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059535
- Sponsor's protocol ID
- 2021-A01321-40
- Acronym
- Cryogenou
- Status last verified
- May 2025
- First submitted
- 17 Sep 2021
- Last updated
- 16 May 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoneurolysis of the Saphenous Nerve or Geniculate Nerves: Impact on Postoperative Pain and Rehabilitation in Prosthetic Knee Surgery
- ClinicalTrials.gov ID
- NCT05059535
- Acronym / sponsor ID
- Cryogenou / 2021-A01321-40
- Conditions
- Knee Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the recruitment rate is far too low despite an 18-month extension of the inclusion period
- Enrolment
- 52 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 28 Sep 2021 (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.
Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cryoneurolysis of the saphenous nerve | Experimental | Drug: standard pain relieversA cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty |
| cryoneurolysis of geniculate nerves | Experimental | Drug: standard pain relieversA cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty |
| control | Placebo comparator | Drug: standard pain relieversNo cryoneurolysis will be performed before the knee arthroplasty |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and ≤ 80 years;
- Patient to undergo prosthetic knee surgery;
- Patient in good health (ASA score 1 to 3);
- Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.
Key exclusion criteria (11 listed)
- Known intolerance to any of the products administered during surgery or cryoneurolysis;
- Patient with an electric implant;
- Patient with a contraindication to cryoanalgesia (coagulation disorders, infections, nerve damage);
- Drug addict patient;
- Intervention on septic bone;
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 |
|---|---|---|
| standard pain relieversAlso: Standard pain relievers in accordance with the current practiceKnee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice | Drug | control, cryoneurolysis of geniculate nerves, cryoneurolysis of the saphenous nerve |
Primary outcome
90 ° flexion pain 2 days after the arthroscopy
Time frame: 2 days
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
9 secondary outcomes
90 ° flexion pain 1 day after the arthroscopy
Time frame: 1 day
90 ° flexion pain 7 days after the arthroscopy
Time frame: 7 days
90 ° flexion pain 30 days after the arthroscopy
Time frame: 30 days
90 ° flexion pain 90 days after the arthroscopy
Time frame: 90 days
pain at rest at Day 1
Time frame: 1 day
pain at rest at Day 2
Time frame: 2 days
pain at rest at Day 7
Time frame: 7 days
pain at rest at Day 30
Time frame: 30 days
pain at rest at Day 90
Time frame: 90 days
Results and safety
The study was stopped early (reason given: the recruitment rate is far too low despite an 18-month extension of the inclusion period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing standard pain relievers in people with Knee Injuries, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 May 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the recruitment rate is far too low despite an 18-month extension of the inclusion period). Results are not available in the source record.
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?
90 ° flexion pain 2 days after the arthroscopy (time frame: 2 days). 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 16 May 2025.