The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06991231
Status
Recruiting
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Conditions

  • Post-Operative Pain
  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 13, 2025
Status verified
Mar 2026
Primary completion
Sep 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
215 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Opioid Consumption during Post-Procedural Follow-Up Period [ Time Frame: Month 3 Post-Operation (Approximately Week 8-9) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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