Cryoablation for Total Knee Replacement

Overseen By Daniel Warren

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cold-related conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

396 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joshua Rozell, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals who are undergoing total knee replacement surgery and are looking to manage postoperative pain. Specific eligibility criteria details were not provided, so participants should inquire about inclusion and exclusion criteria.

Inclusion Criteria

I am medically cleared and scheduled for surgery.

I am scheduled for knee replacement surgery due to arthritis.

Exclusion Criteria

I have a condition that worsens with cold, like Raynaud's or cold urticaria.

I had surgery for a fracture, infection, or cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

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

2-3 weeks

Treatment

Participants undergo total knee arthroplasty (TKA) with or without cryoablation

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of knee function and opioid consumption

8-9 weeks

Treatment Details

Interventions

• Cryoablation

Trial Overview The study is testing the effectiveness of cryoablation—a technique that uses extreme cold to reduce pain—when combined with total knee arthroplasty (knee replacement surgery). Participants will be randomly assigned to receive either standard knee surgery or surgery with added cryoablation.

Participant Groups

Group I: Total knee arthroplasty (TKA) + Cryoablation Experimental Treatment 2 Interventions

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

Group II: TKA Only Active Control 1 Intervention

Patients will NOT receive cryoablation prior to the TKA procedure.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+