Cryoneurolysis before total knee replacement surgery
Official title: Association of Pre-operative Genicular Nerves Cryoneurolysis With Improved Pain and Function in Patients Undergoing Total Knee Arthroplasty
Run by Attikon Hospital · NCT07425457 · Data updated 2026-11-12
This trial will test whether freezing the genicular nerves at least 24 hours before total knee replacement reduces long-term pain and improves recovery for adults having primary TKA for osteoarthritis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Attikon Hospital Academic / other |
| Locations | 1 site (Athens) |
| Status | Recruiting |
| Started | January 2, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT07425457 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older undergoing primary total knee arthroplasty for osteoarthritis who are cognitively able to self-report pain and provide informed consent are ideal candidates.
✕Probably not a fit
Patients with cancer-related knee pain, significant neurological or psychiatric conditions that interfere with assessments, chronic opioid users, or those undergoing revision knee replacement are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center, randomized (1:1) comparative trial enrolling adults scheduled for primary total knee arthroplasty for osteoarthritis. The intervention arm receives percutaneous CT-guided cryoneurolysis of the upper lateral, upper medial, and lower medial genicular nerves using 17-gauge probes and a standardized freeze–thaw–freeze protocol (5 min freeze, 4 min passive thaw, 5 min freeze) performed under prophylactic antibiotics at least 24 hours before surgery. Participants are randomized to cryoneurolysis plus TKA versus TKA alone and are followed for six months with serial measures of pain, physical function, and quality of life; procedural imaging confirms probe placement and screens for immediate complications. Outcomes will compare long-term pain and functional recovery between groups.
Why it matters
Potential benefit: If successful, this approach could reduce persistent post-TKA pain, speed functional recovery, and reduce postoperative opioid needs.
How similar studies have gone: Prior small randomized and observational studies of genicular nerve cryoablation for knee osteoarthritis or perioperative analgesia have shown short-term pain relief, but evidence for improved long-term outcomes after TKA is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Attikon University General Hospital
Athens, Greece Recruiting
Study contacts
- Study coordinator: Dimitrios Filippiadis, MD, PhD, EBIR, MSc
- Email: dfillipiadis@yahoo.gr
- Phone: +306948513104
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.