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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Cryoablation to reduce pain after total knee replacement

Official title: The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty - A Randomized Prospective Clinical Trial

Run by NYU Langone Health · NCT06991231 · Data updated 2026-11-12

This trial tests whether adding cryoablation during total knee replacement helps people have less pain and need fewer opioid pain medicines.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment215 (estimated)
SponsorNYU Langone Health
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedJune 13, 2025
Main results expectedSeptember 1, 2026
Study endsJanuary 1, 2027
Registry record updatedApril 3, 2026
Trial IDNCT06991231 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • NYU Langone Health
    New York, New York, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Post Operative Pain 71Total Knee Arthroplasty 68NYU Langone Health 183
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.