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NCT Number: NCT07425457

Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial)

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.

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Key information

Conditions

Arthroplasty Agnosia Chronic Pain Genicular Nerves Knee Arthritis Osteoarthritis Knee Arthroplasty, Total Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Replacement Material Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Attikon University General Hospital

Athens, 12462, Greece

Location status: Recruiting

Location contact

Vasileios Balomenos, MD, MSc, PhD(c)

CONTACT

[email protected]

+306945297496

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years undergoing primary TKA for osteoarthritis.
  • Cognitively normal and able to self-assess pain and function.
  • Provide written informed consent.

Exclusion criteria

  • Cancer-related knee pain.
  • Neurological, psychiatric, or medical conditions interfering with assessment.
  • Chronic opioid users.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score

    Time frame: 3 and 6 months post-op

    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.

  2. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 3 and 6 months post-op

    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. The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Classification System

    Time frame: 6 months post-op

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitrios Filippiadis, MD, PhD, EBIR, MSc

CONTACT

[email protected]

+306948513104

Vasileios Balomenos, MD, MSc, PhD(c)

CONTACT

[email protected]

+30645297496

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

Association of Pre-operative Genicular Nerves Cryoneurolysis With Improved Pain and Function in Patients Undergoing Total Knee Arthroplasty

Acronym: CRYO-TKA

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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