Trials / Recruiting
RecruitingNCT07425457
Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial)
Association of Pre-operative Genicular Nerves Cryoneurolysis With Improved Pain and Function in Patients Undergoing Total Knee Arthroplasty
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Attikon Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Conditions
- Arthroplasty
- Replacement Material
- Knee Arthritis Osteoarthritis
- Knee Arthroplasty, Total
- Genicular Nerves
- Chronic Pain
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-01-02
- Primary completion
- 2027-12-31
- Completion
- 2028-03-31
- First posted
- 2026-02-20
- Last updated
- 2026-02-20
Locations
1 site across 1 country: Greece
Source: ClinicalTrials.gov record NCT07425457. Inclusion in this directory is not an endorsement.