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Cryoablation for Post-Operative Pain after Total Knee Arthroplasty

This study is looking at whether cryoablation (a procedure using extreme cold) can help reduce pain and opioid use after total knee arthroplasty (TKA), which is knee replacement surgery. You might be able to join if you are at least 18 years old, need a primary total knee replacement for osteoarthritis or inflammatory arthritis, and have been cleared for surgery. The study will compare patients who receive TKA with cryoablation to those who receive TKA alone. Researchers will measure how much opioid medication you use and your knee function (using the KOOS, JR. Score) about three months after your surgery to see if cryoablation is helpful. The current recruitment status is unclear.

Study design
This is a randomized study with 215 planned participants. Participants will be randomly assigned to receive either total knee arthroplasty with cryoablation or total knee arthroplasty alone.
What's involved
You would undergo total knee arthroplasty as part of your standard care, and if assigned to the cryoablation group, you would also receive cryoablation on the leg of the knee being operated on.
Compensation
Not stated in the trial record.
Follow-up
Your opioid consumption and knee function will be measured about three months after your operation.

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NCT06991231

The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty

Recruiting
NAAges 18+InterventionalSupportive care
NYU Langone Health
~215 participants
Updated 2026-04-03 on ClinicalTrials.gov
What's tested:Total knee arthroplasty (TKA)Cryoablation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Opioid Consumption during Post-Procedural Follow-Up Period
Measured over Month 3 Post-Operation (Approximately Week 8-9)
+1 more outcome measured

Conditions

Post-Operative Pain
Total Knee Arthroplasty

Explore related trials

ArthritisOsteoarthritis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Joshua Rozell, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Daniel Waren
[email protected]
212-598-6245
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Patients with cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, and Raynaud's disease)
Surgery for fracture, infection, or malignancy

What this trial measures

  • Opioid Consumption during Post-Procedural Follow-Up PeriodMonth 3 Post-Operation (Approximately Week 8-9)

    Measured as morphine milligram equivalents.

  • Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) ScoreMonth 3 Post-Operation (Approximately Week 8-9)

    KOOS, JR. is a 7-item assessment of how participants feel about their knee and how well they are able to do usual activities. Each item is rated on a Likert scale; the raw score is the sum of item responses. The raw score is transformed into a total score ranging from 0-100, where 0 indicates total knee disability and 100 represents perfect knee health.