The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty

NYU Langone Health

Status: Not yet enrolling

Conditions: Total Knee Arthroplasty; Post-Operative Pain

Treatments: Procedure: Total knee arthroplasty (TKA); Device: Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06991231

25-00306

Details and patient eligibility

About

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.

Enrollment: 396 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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396 participants in 2 patient groups

Total knee arthroplasty (TKA) + Cryoablation

Experimental group

Description:

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

Treatment:

Device: Cryoablation

Procedure: Total knee arthroplasty (TKA)

TKA Only

Active Comparator group

Description:

Patients will NOT receive cryoablation prior to the TKA procedure.

Treatment:

Procedure: Total knee arthroplasty (TKA)