Cryoablation to reduce pain after total knee replacement
The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty - A Randomized Prospective Clinical Trial
This trial tests whether adding cryoablation during total knee replacement helps people have less pain and need fewer opioid pain medicines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 215 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06991231 on ClinicalTrials.gov |
What this trial studies
This randomized 1:1 study will compare standard total knee arthroplasty with and without perioperative cryoablation applied around the knee. Eligible patients are those cleared for elective primary TKA for osteoarthritis or inflammatory arthritis and will be randomized to receive cryoablation plus surgery or surgery alone. Primary outcomes include patient-reported outcome measures (PROMs) and opioid consumption in the postoperative period, with follow-up visits at the surgical center. The single-center trial is conducted at NYU Langone Health and excludes patients with cold-related conditions or those having surgery for fracture, infection, or malignancy.
Who should consider this trial
Good fit: Ideal candidates are adults cleared for elective primary total knee arthroplasty for osteoarthritis or inflammatory arthritis who can undergo surgery and return for follow-up at the study center.
Not a fit: Patients with cold-related disorders (for example, cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, or Raynaud's) or those having TKA for fracture, infection, or malignancy are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, cryoablation could lower post-operative pain and reduce opioid use after total knee replacement.
How similar studies have performed: Prior small trials and pilot studies of perioperative cryoablation or cryoneurolysis for knee procedures have shown promising reductions in pain and opioid use, but larger definitive trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis. * Patients have been medically cleared and scheduled for surgery Exclusion Criteria: * Patients with cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, and Raynaud's disease) * Surgery for fracture, infection, or malignancy
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Rozell, MD — NYU Langone Health
- Study coordinator: Daniel Waren
- Email: Daniel.waren@nyulangone.org
- Phone: 212-598-6245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.