Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07425457

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

Led by Attikon Hospital · Updated on 2026-02-20

100

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adults undergoing total knee arthroplasty (TKA) to see if performing percutaneous cryoneurolysis on the genicular nerves before surgery can reduce pain and improve physical function. The study compares patients who receive this nerve-freezing procedure at least 24 hours before TKA with those who have standard TKA without cryoneurolysis. The goal is to assess if the intervention helps with long-term recovery and quality of life. Participants in the intervention group will undergo CT-guided cryoneurolysis targeting the upper lateral, upper medial, and lower medial genicular nerves using 17-gauge cryoprobes. The procedure involves freezing the nerves in cycles of 5 minutes freezing, 4 minutes passive thawing, and another 5 minutes freezing. Imaging guidance confirms probe placement and checks for immediate complications. The control group will receive standard TKA without the nerve-freezing treatment. During the study, participants will be monitored for changes in pain severity one month after surgery as the primary outcome. Secondary measures include knee function and osteoarthritis symptoms at 3 and 6 months postoperatively, as well as safety assessments at 6 months. Participants will be followed and evaluated over six months to track recovery, physical function, and any adverse effects related to the procedures.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older undergoing primary total knee arthroplasty for osteoarthritis
  • Cognitively normal and able to self-assess pain and physical function
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Knee pain related to cancer
  • Neurological, psychiatric, or medical conditions that interfere with pain and function assessment
  • Chronic opioid use

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Cryoneurolysis and Pre-operative Care

Duration - 1 day

Participants in the intervention group receive CT-guided cryoneurolysis targeting specific genicular nerves at least 24 hours before total knee arthroplasty (TKA).

1 visit (in-person) prior to surgery

Total Knee Arthroplasty (TKA)

Duration - 1 day

Participants undergo standard total knee arthroplasty surgery.

1 visit (in-person) for surgery

Post-operative Follow-up

Duration - 6 months

Participants are followed after surgery to assess pain and knee function over time.

Visits at 1 month, 3 months, and 6 months postoperatively

Trial Site Locations

Total: 1 location

1

Attikon University General Hospital

Athens, Greece, 12462

Actively Recruiting

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Research Team

D

Dimitrios Filippiadis, MD, PhD, EBIR, MSc

V

Vasileios Balomenos, MD, MSc, PhD(c)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Predictors of Persistent Post-Surgical Pain Following Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of Observational Studies.

Vahid Ashoorion, Behnam Sadeghirad, Li Wang...

https://pubmed.ncbi.nlm.nih.gov/36255268

Cryoneurolysis Associated With Improved Pain, Function, and Sleep in Patients Following total Knee Arthroplasty: Use of a New Real-World Registry.

Michael A Mont, Jennifer H Lin, Andrew I Spitzer...

https://pubmed.ncbi.nlm.nih.gov/38942249