RecruitingNot ApplicableNCT06991231

The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty

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


Sponsor

NYU Langone Health

Enrollment

215 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Summary

The purpose of this study is to evaluate the efficacy of cryoablation use on patient-reported outcomes (PROMs) and opioid consumption following total knee arthroplasty. This is a randomized study that will involve a 1:1 randomization to total knee arthroplasty +/- cryoablation.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria2

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

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Interventions

PROCEDURETotal knee arthroplasty (TKA)

Administered as part of patient standard of care.

DEVICECryoablation

Cryoablation will be administered on the leg of the knee indicated for surgery.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT06991231