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

NCT07425457 | Recruiting

• 1 other identifier: 499
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arthroplasty; Replacement Material; Knee Arthritis Osteoarthritis; Knee Arthroplasty, Total; Genicular Nerves; Chronic Pain

Keywords

Cryoneurolysis; Interventional Radiology; Pain Management; Post-operative recovery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Knee Injury and Osteoarthritis Outcome Score

  3 and 6 months post-op

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  3 and 6 months post-op

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

  6 months post-op

Study Arms (2)

Cryoneurolysis + TKA Arm

OTHER

CT-guided cryoneurolysis of upper medial, upper lateral, and lower medial genicular nerves ≥24 hours before TKA.

Procedure: CT-guided Cryoneurolysis of the Genicular Nerves

Control Arm

NO INTERVENTION

Standard total knee arthroplasty without preoperative cryoneurolysis.

Interventions

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.

Cryoneurolysis + TKA Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon University General Hospital

Athens, 12462, Greece

RECRUITING

Related Publications (4)

• Dasa V, Larijani GE, Kostajny B, et al. Percutaneous freezing of genicular nerves (cryoneurolysis) for pain management after total knee arthroplasty. Knee. 2016;23(3):523-528. doi:10.1016/j.knee.2016.01.015.

  BACKGROUND

• Ashoorion V, et al. Predictors of persistent post-surgical pain following total knee arthroplasty: a systematic review and meta-analysis. Pain Med. 2023;24(4):369-381. doi:10.1093/pm/pnac144.

  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;102(5):273-278. doi:10.1016/j.diii.2020.11.007.

  BACKGROUND

• Mont MA, Mihalko WM, Chahal J, et al. Cryoneurolysis Associated With Improved Pain, Function, and Sleep in Patients Following Total Knee Arthroplasty. J Arthroplasty. 2025;40(1):92-101. doi:10.1016/j.arth.2024.05.035.

  BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Dimitrios Filippiadis, MD, PhD, EBIR, MSc

CONTACT

+306948513104; dfillipiadis@yahoo.gr

Vasileios Balomenos, MD, MSc, PhD(c)

CONTACT

+30645297496; balomenosv@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 20, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available from June 1st, 2026. End date has not beed decided yet.

Locations

GR (1)