ArthroplastyCRYO-TKANCT07425457
Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial)
A study testing CT-guided Cryoneurolysis of the Genicular Nerves in people with Arthroplasty and Replacement Material, run by Attikon Hospital at 1 site in Greece.
Trial summary
Approximately 20-30% of patients experience persistent pain after a Total Knee Arthroplasty (TKA). This study investigates whether percutaneous cryoneurolysis of genicular nerves can reduce pain and improve physical function when performed at least 24 hours before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement Material, Knee Arthritis Osteoarthritis
- What is being tested?
- CT-guided Cryoneurolysis of the Genicular Nerves
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 2 Jan 2026to 31 Mar 2028
- 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
- Adults ≥18 years undergoing primary TKA for osteoarthritis.
- Cognitively normal and able to self-assess pain and function.
- Provide written informed consent.
Who cannot join
- Cancer-related knee pain.
- Neurological, psychiatric, or medical conditions interfering with assessment.
- Chronic opioid users.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Attikon University General Hospital
Athens, 12462
Vasileios Balomenos, MD, MSc, PhD(c), +306945297496, balomenosv@gmail.com
About this study
Official title: Association of Pre-operative Genicular Nerves Cryoneurolysis With Improved Pain and Function in Patients Undergoing Total Knee Arthroplasty
Approximately 20-30% of patients experience persistent pain after a Total Knee Arthroplasty (TKA). This study investigates whether percutaneous cryoneurolysis of genicular nerves can reduce pain and improve physical function when performed at least 24 hours before surgery. Participants will be randomized to receive either the cryoneurolysis procedure + TKA or TKA only. Results will be tracked for 6 months to see if the intervention improves long-term recovery and quality of life.
Read the detailed description
The current study is a prospective, single-center, randomized comparative trial (1:1 ratio). In the intervention group, cryoneurolysis is performed under imaging guidance targeting the upper lateral and medial and the lower medial genicular nerves. Under prophylactic antibiosis, and imaging guidance 17Gauge cryoprobes will be percutaneously placed at the level of the upper lateral and medial and the lower medial genicular nerves. The final position of each cryo probe will be verified with imaging guidance. Cryoneurolysis protocol will be 5min freezing-4min passive thawing-5min freezing. Post-interventional imaging will verify lack of potential immediate complications
- Conditions
- Arthroplasty, Replacement Material, Knee Arthritis Osteoarthritis, Knee Arthroplasty, Total, Genicular Nerves, Chronic Pain
- Being tested
- CT-guided Cryoneurolysis of the Genicular Nerves
- Keywords
- Cryoneurolysis, Interventional Radiology, Pain Management, Post-operative recovery
- Medical subject headings
- Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided Cryoneurolysis of the Genicular NervesProcedure or surgery
Percutaneous CT-guided cryoneurolysis using up to three cryoprobes (-20°C to -100°C) for temporary sensory nerve interruption.
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolysis + TKA Arm | Other | CT-guided cryoneurolysis of upper medial, upper lateral, and lower medial genicular nerves ≥24 hours before TKA. Receives: Procedure: CT-guided Cryoneurolysis of the Genicular Nerves |
| Control Arm | No intervention | Standard total knee arthroplasty without preoperative cryoneurolysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity
Change in pain severity (Brief Pain Inventory-BPI) - Baseline to 1 month postoperatively.
The BPI typically assesses two primary domains using a 0 to 10 numerical rating scale:
Pain Intensity: Patients rate their pain at its "worst," "least," and "average" over the last 24 hours, as well as their pain "right now." 0 = No Pain 10 = Pain as bad as you can imagine
Pain Interference: Patients rate how much their pain interferes with seven daily activities (General Activity, Mood, Walking Ability, Normal Work, Relations with others, Sleep, and Enjoyment of Life).
0 = Does not interfere 10 = Completely interferes
Because higher numbers represent more intense pain and more significant disruption to life, a reduction in score over time is the goal of most clinical treatments.
Measured: 1 month postoperatively
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score
The Knee Injury and Osteoarthritis Outcome Score is a 42-item questionnaire designed to assess short-term and long-term consequences of knee injury. It covers five subscales: Pain, Symptoms, ADL, Sport/Rec, and QOL.
Each subscale is transformed to a 0 to 100 scale. Unlike pain-only scales, higher scores mean a better outcome, with 100 representing a perfectly functional knee and 0 representing extreme knee problems.
Measured: 3 and 6 months post-op
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Osteoarthritis Index is the "gold standard" for evaluating patients with hip and knee osteoarthritis.
It measures 24 items divided into pain, stiffness, and physical function. Using a Likert scale (0-4 per item), the total score ranges from 0 to 96. For the WOMAC, higher scores mean a worse outcome, reflecting increased pain and significant physical disability.
Measured: 3 and 6 months post-op
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Classification System
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Classification System is a tool used by clinicians to standardize the reporting of complications in interventional radiology.
It ranks adverse events from Grade 1 to Grade 6. A Grade 1 signifies a minor issue with no therapy required, while a Grade 6 indicates patient death.
Therefore, higher scores mean a worse outcome, representing a higher severity of medical complications.
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start2 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ArthroplastyStudies 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
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios Balomenos, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425457
- Sponsor's protocol ID
- 499
- Acronym
- CRYO-TKA
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available upon reasonable request following publication of primary results.
Publications
Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.
PubMed 26875052Ashoorion V, Sadeghirad B, Wang L, Noori A, Abdar M, Kim Y, Chang Y, Rehman N, Lopes LC, Couban RJ, Aminilari M, Malektojari A, Ghazizadeh S, Rehman Y, Ghasemi M, Adili A, Guyatt GH, Busse JW. Predictors of Persistent Post-Surgical Pain Following Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of Observational Studies. Pain Med. 2023 Apr 3;24(4):369-381. doi: 10.1093/pm/pnac154.
PubMed 36255268Filippiadis D, Efthymiou E, Tsochatzis A, Kelekis A, Prologo JD. Percutaneous cryoanalgesia for pain palliation: Current status and future trends. Diagn Interv Imaging. 2021 May;102(5):273-278. doi: 10.1016/j.diii.2020.11.007. Epub 2020 Dec 3.
PubMed 33281081Mont MA, Lin JH, Spitzer AI, Dasa V, Rivadeneyra A, Rogenmoser D, Concoff AL, Ng MK, DiGiorgi M, DySart S, Urban J, Mihalko WM. Cryoneurolysis Associated With Improved Pain, Function, and Sleep in Patients Following total Knee Arthroplasty: Use of a New Real-World Registry. J Arthroplasty. 2025 Jan;40(1):92-101.e3. doi: 10.1016/j.arth.2024.06.054. Epub 2024 Jun 26.
PubMed 38942249Balomenos V, Moschovaki-Zeiger O, Koulouvaris P, Savvidou O, Mastrokalos D, Kelekis N, Fillipiadis D, Koulalis D. Preoperative CT-Guided Cryoneurolysis of the Genicular Nerves Before Total Knee Arthroplasty: Study Protocol for a Prospective Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2026 Sep 6. doi: 10.1007/s00270-026-04588-z. Online ahead of print.
PubMed 42702647
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Pre-operative Genicular Nerves Cryoneurolysis With Improved Pain and Function in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07425457
- Acronym / sponsor ID
- CRYO-TKA / 499
- Conditions
- Arthroplasty, Replacement Material, Knee Arthritis Osteoarthritis, Knee Arthroplasty, Total, Genicular Nerves, Chronic Pain
- Keywords
- Cryoneurolysis, Interventional Radiology, Pain Management, Post-operative recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 20 Feb 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.
Approximately 20-30% of patients experience persistent pain after a Total Knee Arthroplasty (TKA). This study investigates whether percutaneous cryoneurolysis of genicular nerves can reduce pain and improve physical function when performed at least 24 hours before surgery. Participants will be randomized to receive either the cryoneurolysis procedure + TKA or TKA only. Results will be tracked for 6 months to see if the intervention improves long-term recovery and quality of life.
Detailed description
The current study is a prospective, single-center, randomized comparative trial (1:1 ratio). In the intervention group, cryoneurolysis is performed under imaging guidance targeting the upper lateral and medial and the lower medial genicular nerves. Under prophylactic antibiosis, and imaging guidance 17Gauge cryoprobes will be percutaneously placed at the level of the upper lateral and medial and the lower medial genicular nerves. The final position of each cryo probe will be verified with imaging guidance. Cryoneurolysis protocol will be 5min freezing-4min passive thawing-5min freezing. Post-interventional imaging will verify lack of potential immediate complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoneurolysis + TKA Arm | Other | Procedure: CT-guided Cryoneurolysis of the Genicular NervesCT-guided cryoneurolysis of upper medial, upper lateral, and lower medial genicular nerves ≥24 hours before TKA. |
| Control Arm | No intervention | –Standard total knee arthroplasty without preoperative cryoneurolysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years undergoing primary TKA for osteoarthritis.
- Cognitively normal and able to self-assess pain and function.
- Provide written informed consent.
Key exclusion criteria (3 listed)
- Cancer-related knee pain.
- Neurological, psychiatric, or medical conditions interfering with assessment.
- Chronic opioid users.
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 |
|---|---|---|
| CT-guided Cryoneurolysis of the Genicular NervesPercutaneous CT-guided cryoneurolysis using up to three cryoprobes (-20°C to -100°C) for temporary sensory nerve interruption. | Procedure or surgery | Cryoneurolysis + TKA Arm |
Primary outcome
Change in pain severity
Time frame: 1 month postoperatively
Change in pain severity (Brief Pain Inventory-BPI) - Baseline to 1 month postoperatively. The BPI typically assesses two primary domains using a 0 to 10 numerical rating scale: Pain Intensity: Patients rate their pain at its "worst," "least," and "average" over the last 24 hours, as well as their pain "right now." 0 = No Pain 10 = Pain as bad as you can imagine Pain Interference: Patients rate how much their pain interferes with seven daily activities (General Activity, Mood, Walking Ability, Normal Work, Relations with others, Sleep, and Enjoyment of Life). 0 = Does not interfere 10 = Completely interferes Because higher numbers represent more intense pain and more significant disruption to life, a reduction in score over time is the goal of most clinical treatments.
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: 3 and 6 months post-op
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 3 and 6 months post-op
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Classification System
Time frame: 6 months post-op
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 20 Feb 2026.
- Background: PubMed 26875052Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.
- Background: PubMed 36255268Ashoorion V, Sadeghirad B, Wang L, Noori A, Abdar M, Kim Y, Chang Y, Rehman N, Lopes LC, Couban RJ, Aminilari M, Malektojari A, Ghazizadeh S, Rehman Y, Ghasemi M, Adili A, Guyatt GH, Busse JW. Predictors of Persistent Post-Surgical Pain Following Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of Observational Studies. Pain Med. 2023 Apr 3;24(4):369-381. doi: 10.1093/pm/pnac154.
- Background: PubMed 33281081Filippiadis D, Efthymiou E, Tsochatzis A, Kelekis A, Prologo JD. Percutaneous cryoanalgesia for pain palliation: Current status and future trends. Diagn Interv Imaging. 2021 May;102(5):273-278. doi: 10.1016/j.diii.2020.11.007. Epub 2020 Dec 3.
- Background: PubMed 38942249Mont MA, Lin JH, Spitzer AI, Dasa V, Rivadeneyra A, Rogenmoser D, Concoff AL, Ng MK, DiGiorgi M, DySart S, Urban J, Mihalko WM. Cryoneurolysis Associated With Improved Pain, Function, and Sleep in Patients Following total Knee Arthroplasty: Use of a New Real-World Registry. J Arthroplasty. 2025 Jan;40(1):92-101.e3. doi: 10.1016/j.arth.2024.06.054. Epub 2024 Jun 26.
- Derived from this study: PubMed 42702647Balomenos V, Moschovaki-Zeiger O, Koulouvaris P, Savvidou O, Mastrokalos D, Kelekis N, Fillipiadis D, Koulalis D. Preoperative CT-Guided Cryoneurolysis of the Genicular Nerves Before Total Knee Arthroplasty: Study Protocol for a Prospective Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2026 Sep 6. doi: 10.1007/s00270-026-04588-z. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified data will be available upon reasonable request following publication of primary results.
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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 CT-guided Cryoneurolysis of the Genicular Nerves in people with Arthroplasty and Replacement Material, run by Attikon Hospital at 1 site in Greece.
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 3 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 20 Feb 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 Greece. 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?
Contact Dimitrios Filippiadis, MD, PhD, EBIR, MSc (+306948513104, dfillipiadis@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity (time frame: 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425457, which also lists 5 linked publications.
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 20 Feb 2026.