Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT-guided Cryoneurolysis of the Genicular Nerves.
- Who it may be relevant to
- Registry conditions: Arthroplasty, Replacement Material, Knee Arthritis Osteoarthritis, Knee Arthroplasty, Total. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association of Pre-operative Genicular Nerves Cryoneurolysis With Improved Pain and Function in Patients Undergoing Total Knee Arthroplasty
Overview
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
Interventions
- Procedure CT-guided Cryoneurolysis of the Genicular Nerves
Percutaneous CT-guided cryoneurolysis using up to three cryoprobes (-20°C to -100°C) for temporary sensory nerve interruption.
Primary outcome measures
- Change in pain severity [Time frame: 1 month postoperatively]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Greece · 1 center
- Attikon University General Hospital — Athens
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. PMID 26875052
- 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. PMID 36255268
- 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. PMID 33281081
- 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. PMID 38942249
Identifiers
NCT: NCT07425457 · 499