Recruiting

Cryoablation

Sponsor:

NYU Langone Health

Code:

NCT06991231

Conditions

Post-Operative Pain

Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total knee arthroplasty (TKA)

Cryoablation

Study Details

Brief 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.

Conditions

Post-Operative Pain

Total Knee Arthroplasty

Study ID

NCT06991231

Start date

Jun 13, 2025

Status verified date

Mar, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

215 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Total knee arthroplasty (TKA) + Cryoablation

Patients will receive cryoablation during the two to three weeks prior to the TKA procedure.

active comparator: TKA Only

Patients will NOT receive cryoablation prior to the TKA procedure.

Interventions

Total knee arthroplasty (TKA)

Administered as part of patient standard of care.

Cryoablation

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

Primary outcome measure

  • Opioid Consumption during Post-Procedural Follow-Up Period [ Time Frame: Month 3 Post-Operation (Approximately Week 8-9) ]
  • Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score [ Time Frame: Month 3 Post-Operation (Approximately Week 8-9) ]

Central Contacts and Locations

Central contacts

Daniel Waren

212-598-6245Daniel.waren@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-04-03.