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NCT Number: NCT06991231

The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty

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.

Recruiting

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee arthroplasty (TKA)

Procedure

Administered as part of patient standard of care.

Cryoablation

Device

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

Primary outcomes

  1. Opioid Consumption during Post-Procedural Follow-Up Period

    Time frame: Month 3 Post-Operation (Approximately Week 8-9)

    Measured as morphine milligram equivalents.

  2. Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score

    Time frame: Month 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Waren

CONTACT

[email protected]

212-598-6245

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 27, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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