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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoneurolysis + TKA Arm | Other | CT-guided cryoneurolysis of upper medial, upper lateral, and lower medial genicular nerves ≥24 hours before TKA. |
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| Control Arm | No Intervention | Standard total knee arthroplasty without preoperative cryoneurolysis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-guided Cryoneurolysis of the Genicular Nerves | Procedure | Percutaneous CT-guided cryoneurolysis using up to three cryoprobes (-20°C to -100°C) for temporary sensory nerve interruption. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dimitrios Filippiadis, MD, PhD, EBIR, MSc | Contact | +306948513104 | dfillipiadis@yahoo.gr | |
| Vasileios Balomenos, MD, MSc, PhD(c) | Contact | +30645297496 | balomenosv@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attikon University General Hospital | Recruiting | Athens | 12462 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26875052 | Background | 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. | |
| 36255268 | Background | Ashoorion 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. |
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De-identified data will be available upon reasonable request following publication of primary results.
IPD and supporting information will be available from June 1st, 2026. End date has not beed decided yet.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2025 | Feb 19, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. | 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. | 6 months post-op |
| 33281081 | Background | Filippiadis 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. |
| 38942249 | Background | Mont 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. |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |